Product Code: EIH
FDA class 2
21 CFR 872.6660
Powder, Porcelain
Dental
Dental Porcelain Powder is a ceramic material used in dental laboratories to fabricate porcelain-fused-to-metal crowns, all-ceramic restorations, and dental veneers by firing layers of fine ceramic powder to create lifelike tooth-colored prosthetics. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and special controls. The product code is EIH, regulated under 21 CFR 872.6660 in the Dental (DE) specialty. This device is eligible for third-party review.
510(k)s
482
FEI Numbers
158
Registration Numbers
158
Unique Applicants
224
Years Active
49
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Basic Information
- Product Code
- EIH
- Device Class
- FDA class 2
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 482 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260859 | Rosetta SM, Rosetta SP | Jun 11, 2026 | Substantially Equivalent | Hass Corp. |
| K253191 | DCMhotbond zircon | May 21, 2026 | Substantially Equivalent | Dental Creativ Management GmbH |
| K260067 | Eternal Art Porcelain Powders | Apr 09, 2026 | Substantially Equivalent | Shandong Huge Dental Material Corporation |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Mar 30, 2026 | Substantially Equivalent | Bloomden Bioceramics (HuNan) Co., Ltd. |
| K253953 | IPS e.max Zirconia | Mar 10, 2026 | Substantially Equivalent | Ivoclar Vivadent, Inc. |
| K254283 | BruxZir® Shaded 16 PLUS | Jan 30, 2026 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Jan 09, 2026 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K252789 | Glass Ceramic | Dec 08, 2025 | Substantially Equivalent | Shenzhen Xiangtong Co., Ltd. |
| K252446 | BruxZir® NOW | Sep 03, 2025 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K251593 | DenMat Multilayered Zirconia Disc | Aug 25, 2025 | Substantially Equivalent | Denmat Holding, LLC |
| K250063 | ARENA Star, Galaxy Star | Jul 10, 2025 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K250826 | Multi M Series | Jun 12, 2025 | Substantially Equivalent | Dmax Co., Ltd. |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Jun 05, 2025 | Substantially Equivalent | Estetic Ceram AG |
| K250673 | CERABIEN MiLai | May 29, 2025 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K250534 | Biomic Color Opaque | May 20, 2025 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | May 12, 2025 | Substantially Equivalent | United Zirconia |
| K250811 | Dental Zirconia Ceramic | Apr 11, 2025 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Mar 14, 2025 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K250223 | BruxZir® Esthetic NOW | Feb 25, 2025 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K243940 | VITA YZ Multi Translucent | Feb 21, 2025 | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Dec 05, 2024 | Substantially Equivalent | Liaoning Rachcera Material Technology Co., Ltd. |
| K242521 | Estar-ZE | Nov 20, 2024 | Substantially Equivalent | Osstem Implant Co., Ltd. |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Nov 13, 2024 | Substantially Equivalent | Hunan Vsmile Biotechnology Co., Ltd. |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Oct 24, 2024 | Substantially Equivalent | Dentsply Sirona |
| K242458 | ArgenZ MTZ | Oct 24, 2024 | Substantially Equivalent | Argen Corporation |
| K242400 | Dental porcelain powder | Oct 10, 2024 | Substantially Equivalent | Yilink (Tianjin) Biotechnology Co., Ltd. |
| K241151 | LUXEN 5G | Sep 30, 2024 | Substantially Equivalent | Dentalmax Co., Ltd. |
| K233064 | Copra Supreme | Sep 18, 2024 | Substantially Equivalent | Whitepeaks Dental Solutions GmbH |
| K241579 | DD Hybridlayer (multicolored zirconia) | Sep 06, 2024 | Substantially Equivalent | Dental Direkt GmbH |
| K241602 | Kingcera Dental Zirconia Blank | Aug 30, 2024 | Substantially Equivalent | Hunan Qinghao Puzhong Technology Co., Ltd. |
| K241557 | Cercon® yo ML | Aug 28, 2024 | Substantially Equivalent | Dentsply Sirona |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Jul 12, 2024 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K241316 | Zirconia Block | Jul 09, 2024 | Substantially Equivalent | Hunan Hualian Special Ceramics Co., Ltd. |
| K232952 | Copran Zri | Jun 24, 2024 | Substantially Equivalent | Whitepeaks Dental Solutions GmbH |
| K233885 | rainbow Paste Stain SE | Jun 21, 2024 | Substantially Equivalent | Genoss Co., Ltd. |
| K233158 | Copra Smile, Copra Supreme Hyperion | Jun 20, 2024 | Substantially Equivalent | Whitepeaks Dental Solutions GmbH |
| K240672 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) | Jun 07, 2024 | Substantially Equivalent | Zhejiang Zahndent Biotechnology Co., Ltd. |
| K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | May 31, 2024 | Substantially Equivalent | Anhui Miisen Intelligence Technology Co., Ltd. |
| K240772 | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) | May 20, 2024 | Substantially Equivalent | Hunan Ceramaster Material Technology Co., Ltd. |
| K240882 | BruxZir® Esthetic | May 01, 2024 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K240419 | UltraThineer Zirconia Slurry (5Y-B) | Apr 12, 2024 | Substantially Equivalent | Boston Micro Fabrication |
| K240574 | BruxZir® Radiant | Mar 20, 2024 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Mar 19, 2024 | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. |
| K234014 | Obsidian® NOW | Feb 27, 2024 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Feb 23, 2024 | Substantially Equivalent | Genoss Co., Ltd. |
| K232676 | Dental Porcelain Powder | Jan 23, 2024 | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. |
| K232673 | Dental Glass Ceramics | Jan 23, 2024 | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. |
| K233125 | Zirconia Block | Jan 12, 2024 | Substantially Equivalent | Hangzhou Ivista Medical Devices Co., Ltd. |
| K233016 | Dental Glass Ceramics | Dec 21, 2023 | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. |
| K232438 | Dental Glass Ceramics Blocks | Dec 01, 2023 | Substantially Equivalent | Aibodent Biotechnology Co., Ltd. |
| K231687 | Gradual Dental Zirconia Blank | Sep 07, 2023 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K230487 | Dental Lithium Disilicate Glass-Ceramic | Jul 03, 2023 | Substantially Equivalent | Fuzhou Rick Brown Biomaterials Co., Ltd. |
| K231264 | Easy On Universal Glaze & Stain | Jun 30, 2023 | Substantially Equivalent | Doctus Global |
| K223029 | Perfit CL | Jun 20, 2023 | Substantially Equivalent | Vatech Mcis Co., Ltd. |
| K231347 | BruxZir TintEFX Coloring Liquid | Jun 09, 2023 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K222961 | Harvest Conceal ZR Block Out | Jun 02, 2023 | Substantially Equivalent | Harvest Dental Products, LLC |
| K230259 | Soreal Press, Soreal CAD | May 25, 2023 | Substantially Equivalent | Shenzhen Up3D Technology Co., Ltd. |
| K230262 | BruxZir Incisal Coloring Liquid | May 16, 2023 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Mar 31, 2023 | Substantially Equivalent | Topzir Biotech Co., Ltd. |
| K223192 | XT Stain/Glaze | Mar 27, 2023 | Substantially Equivalent | Shenzhen Xiangtong Co., Ltd. |
| K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | Feb 27, 2023 | Substantially Equivalent | Arum Dentistry Co., Ltd. |
| K223194 | Glass Ceramic | Feb 10, 2023 | Substantially Equivalent | Shenzhen Xiangtong Co., Ltd. |
| K222513 | Glass Ceramics | Feb 10, 2023 | Substantially Equivalent | Yilink (Tianjin) Biotechnology Co., Ltd. |
| K213722 | ICE Ceramics, ICE Stains, Fresco | Dec 14, 2022 | Substantially Equivalent | Zirkonzahn Srl |
| K222626 | Dental Zirconia Ceramic | Dec 06, 2022 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K222520 | Zirconia Block | Nov 14, 2022 | Substantially Equivalent | Yilink (Tianjin) Biotechnology Co., Ltd. |
| K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Oct 06, 2022 | Substantially Equivalent | Vatech Acucera, Inc. |
| K220369 | Esthetic Colorant | Sep 23, 2022 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K220816 | BruxZir NOW | Aug 02, 2022 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K221242 | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Jul 29, 2022 | Substantially Equivalent | Hunan Vsmile Biotechnology Co., Ltd. |
| K221429 | KDF Zirconia Disc | Jul 14, 2022 | Substantially Equivalent | Denken-Highdental Co., Ltd. |
| K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Jul 08, 2022 | Substantially Equivalent | Changsha Honchon Technology Co., Ltd. |
| K220960 | BruxZir Opaque Coloring Liquid | Jun 29, 2022 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K220017 | Coloring Liquid | Jun 29, 2022 | Substantially Equivalent | Dongguan Xiangtong Co., Ltd. |
| K213147 | CERABIEN MiLai | Mar 28, 2022 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K212939 | Vintage Prime Press | Mar 18, 2022 | Substantially Equivalent | Shofu Dental Corporation |
| K214005 | Zirconia Dental Ceramics | Feb 18, 2022 | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. |
| K214003 | Dental Zirconia Pre-shaded Block | Feb 18, 2022 | Substantially Equivalent | Shenzhen Yurucheng Dental Materials Co., Ltd. |
| K213570 | Dental Zirconia Ceramic | Jan 07, 2022 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K212548 | LUXEN CL Dental Liquid | Dec 06, 2021 | Substantially Equivalent | Dentalmax Co., Ltd. |
| K213425 | BruxZir Esthetic | Nov 17, 2021 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nov 15, 2021 | Substantially Equivalent | Bloomden Bioceramics (HuNan) Co., Ltd. |
| K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nov 12, 2021 | Substantially Equivalent | Zirdent New Material Co., Ltd. |
| K211308 | INNI-CERA | Oct 04, 2021 | Substantially Equivalent | Aon Co., Ltd. |
| K202952 | Amber Mill Q Series & Amber Mill Direct Series | Aug 26, 2021 | Substantially Equivalent | Hass Corp. |
| K211916 | IPS e.max One | Aug 20, 2021 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K210884 | 1Derful HS, 1Derful HT | Jul 27, 2021 | Substantially Equivalent | 1derful, Inc. |
| K210097 | Estar-Z | Jul 02, 2021 | Substantially Equivalent | Osstem Implant Co., Ltd. |
| K203672 | MAZIC Claro CAD and MAZIC Claro Press | Jul 01, 2021 | Substantially Equivalent | Vericom Co., Ltd. |
| K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Jun 24, 2021 | Substantially Equivalent | Vatech Acucera, Inc. |
| K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | Apr 05, 2021 | Substantially Equivalent | Vatech Acucera, Inc. |
| K201492 | Non-Sterile Zirconia Block | Mar 10, 2021 | Substantially Equivalent | Bioden Co., Ltd. |
| K203351 | Perfit ZR HT Dental Zirconia blank | Mar 08, 2021 | Substantially Equivalent | Vatech Acucera, Inc. |
| K201915 | GenesisZr 4Y+ (ST1100) Zirconia | Feb 23, 2021 | Substantially Equivalent | United Dental Resources Corporation |
| K201608 | GenesisZr UHT700 Zirconia | Jan 28, 2021 | Substantially Equivalent | United Dental Resources Corporation |
| K202629 | Dentsply Sirona Universal Spray Glazes | Jan 20, 2021 | Substantially Equivalent | Dentsply Sirona |
| K202673 | X-cera Pre-shaded Zirconia Blanks | Dec 10, 2020 | Substantially Equivalent | Dongguan Xiangtong Co., Ltd. |
| K193090 | HCG Zirconia Ceramic Block | Oct 29, 2020 | Substantially Equivalent | Hocheng Corporation |
| K192723 | Coloring Liquid | Aug 18, 2020 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K193434 | VITA LUMEX AC | Jul 21, 2020 | Substantially Equivalent | Vita Zahnfabrik GmbH H Rauter & CO |
| K192231 | Dental Glass Ceramics Blocks | Jul 08, 2020 | Substantially Equivalent | Aidite (Qinhuangdao) Technology Co., Ltd. |
| K200131 | BruxZir Steel | Jun 10, 2020 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K192262 | Dental Zirconia Blocks | May 29, 2020 | Substantially Equivalent | De Corematrix Co., Ltd. |
| K193436 | VITA Ambria | May 14, 2020 | Substantially Equivalent | Vita Zahnfabrik GmbH H Rauter & CO |
| K193055 | Purzir Dental Zirconia | May 13, 2020 | Substantially Equivalent | 3DBiocad |
| K193588 | DD Contrast | Apr 16, 2020 | Substantially Equivalent | Dental Direkt GmbH |
| K192535 | Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia | Jan 31, 2020 | Substantially Equivalent | Qinhuangdao Audental Metal Technology Co., Ltd. |
| K193060 | Noritake Super Porcelain EX-3 | Jan 30, 2020 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K192251 | Livento Press, Soprano 10, Soprano | Jan 15, 2020 | Substantially Equivalent | Cendres+Metaux SA |
| K190112 | Non-Sterile Zirconia Block | Dec 20, 2019 | Substantially Equivalent | Fine Advanced Compound Co., Ltd. |
| K191903 | BruxZir GT (Gum Tissue) Color | Nov 22, 2019 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K190518 | Color Liquid, Vita Liquid | Nov 22, 2019 | Substantially Equivalent | Zirkonzahn Srl |
| K191304 | EthanZir Zirconia | Nov 04, 2019 | Substantially Equivalent | Besorah Dental Solutions NZ Limited |
| K191631 | ZMAXX Dental Zirconia Blanks | Nov 01, 2019 | Substantially Equivalent | Zmaxx Bioceramics, LLC |
| K191902 | Razor, Everest, U&C Liquid | Oct 11, 2019 | Substantially Equivalent | U&C International Co., Ltd. |
| K191794 | Vintage Art Universal | Oct 03, 2019 | Substantially Equivalent | Shofu Dental Corporation |
| K190569 | Shaders ZR | Jul 29, 2019 | Substantially Equivalent | Digital Age Dental Lab |
| K190436 | KATANA Zirconia Block | May 23, 2019 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K182350 | Dental Ceramic | May 22, 2019 | Substantially Equivalent | Baot Biological Technology Co., Ltd. |
| K190079 | ArgenZ HT+ | Apr 12, 2019 | Substantially Equivalent | The Argen Corporation |
| K183304 | Prettau, ICE, Z-White zirconia blanks | Apr 04, 2019 | Substantially Equivalent | Zirkonzahn Srl |
| K183408 | Jensen Shade Effect Liquids | Mar 20, 2019 | Substantially Equivalent | Jensen Industries, Inc. |
| K183569 | DD cube ONE ML | Feb 14, 2019 | Substantially Equivalent | Dental Direkt GmbH |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | Feb 08, 2019 | Substantially Equivalent | The Argen Corporation |
| K182642 | GenesisZr 4Y Zirconia | Jan 25, 2019 | Substantially Equivalent | United Dental Resources Corporation |
| K181496 | VINTAGE PRO | Dec 18, 2018 | Substantially Equivalent | Shofu Dental Corporation |
| K182068 | Erran Dental Zirconia | Dec 13, 2018 | Substantially Equivalent | Hangzhou Erran Technology Co., Ltd. |
| K181816 | Ceramic Denture Zirconia Ceramics Block | Nov 29, 2018 | Substantially Equivalent | Qinhuangdao Silide Ceramic Technology Co., Ltd. |
| K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent | Nov 15, 2018 | Substantially Equivalent | Yeti Dentalprodukte GmbH |
| K171585 | LUXEN Zr, LUXEN Smile | Oct 31, 2018 | Substantially Equivalent | Dentalmax Co., Ltd. |
| K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Sep 02, 2018 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K170050 | Z-CAD smile | Aug 23, 2018 | Substantially Equivalent | Metoxit AG |
| K180703 | VITA YZ ST and VITA YZ XT | Aug 01, 2018 | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH Co. |
| K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Apr 24, 2018 | Substantially Equivalent | Crown Porcelain Dental Technology Co., Ltd. |
| K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid | Mar 08, 2018 | Substantially Equivalent | Dmax Co., Ltd. |
| K171167 | Prodigio Stain Powder | Dec 13, 2017 | Substantially Equivalent | Operart, LLC |
| K161652 | DIAZIR | Nov 28, 2017 | Substantially Equivalent | Zxtgy (Beijing) Technology Co., Ltd. |
| K172761 | New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) | Nov 17, 2017 | Substantially Equivalent | Shanghai New Century Dental Materials Co., Ltd. |
| K173410 | n!ce for Planmill | Nov 14, 2017 | Substantially Equivalent | Institut Straumann AG |
| K170834 | CERABIEN ZR | Oct 17, 2017 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K171876 | Ceramill Zolid HT+ white | Sep 20, 2017 | Substantially Equivalent | Amann Girrbach AG |
| K163251 | Life Essence Universal Porcelain System | Aug 04, 2017 | Substantially Equivalent | Blue Sky Bio |
| K170894 | Zirconia Dental Ceramics | Aug 01, 2017 | Substantially Equivalent | Chengdu Besmile Biotechnology Co., Ltd. |
| K170885 | DD cubeX2 HS | Aug 01, 2017 | Substantially Equivalent | Dental Direkt GmbH |
| K170986 | KATANA Zirconia Block | Jul 13, 2017 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K163228 | APVolution System | Jun 05, 2017 | Substantially Equivalent | Aesthetic-Press, LLC |
| K163238 | Eclipse Kiss Zirconia | May 04, 2017 | Substantially Equivalent | Ams |
| K170420 | n!ce Glass Ceramic Blocks for Amann Girrbach | Mar 02, 2017 | Substantially Equivalent | Institut Straumann AG |
| K162888 | Cercon | Feb 24, 2017 | Substantially Equivalent | Dentsply Sirona |
| K161025 | priti multidisc ZrO2 High Translucent | Feb 03, 2017 | Substantially Equivalent | Pritidenta GmbH |
| K161219 | Zmaxx T Series | Jan 26, 2017 | Substantially Equivalent | Maxx Digm, Inc. |
| K162677 | L- OVC | Dec 21, 2016 | Substantially Equivalent | Rhondium, Ltd. |
| K160079 | rainbow Shine | Nov 10, 2016 | Substantially Equivalent | Genoss Co., Ltd. |
| K160203 | ADAMANT ZIRCONIA DISC | Oct 19, 2016 | Substantially Equivalent | Adamant Co., Ltd. |
| K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | Sep 16, 2016 | Substantially Equivalent | Institut Straumann AG |
| K152023 | Luminesse Shaded Zirconia SZ | Sep 15, 2016 | Substantially Equivalent | Talladium, Inc. |
| K153130 | Initial LiSi Block | Sep 13, 2016 | Substantially Equivalent | GC America, Inc. |
| K160867 | Pavati Z40.2 Zirconia | Sep 12, 2016 | Substantially Equivalent | Ccri, Inc. |
| K161922 | XP202 | Sep 01, 2016 | Substantially Equivalent | 3M Deutschland GmbH |
| K161269 | CELTRA Press | Aug 12, 2016 | Substantially Equivalent | Dentsply Sirona |
| K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Jul 27, 2016 | Substantially Equivalent | Nissin-Metec China Co., Ltd. |
| K160144 | rainbow LS Block | Jul 21, 2016 | Substantially Equivalent | Genoss Co., Ltd. |
| K160102 | Amber Mill Series and Amber Press Series | Jul 14, 2016 | Substantially Equivalent | Hass Corp. |
| K153136 | Initial LiSi Press | Jun 30, 2016 | Substantially Equivalent | GC America, Inc. |
| K160099 | CEREC SpeedGlaze | Jun 02, 2016 | Substantially Equivalent | Sirona Dental Systems GmbH |
| K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press | May 20, 2016 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K151731 | Rainbow Paste Stain | Apr 15, 2016 | Substantially Equivalent | Genoss |
| K153767 | X-cera Zirconia Blanks | Mar 29, 2016 | Substantially Equivalent | Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. |
| K152274 | MSCB-001 | Mar 25, 2016 | Substantially Equivalent | GC America, Inc. |
| K152247 | ATLANTIS Crown | Jan 29, 2016 | Substantially Equivalent | Dentsply International, Inc. |
| K151846 | Rainbow LS Pressing | Jan 14, 2016 | Substantially Equivalent | Genoss |
| K151842 | Rainbow Shine | Jan 14, 2016 | Substantially Equivalent | Genoss |
| K152392 | VINTAGE LD | Jan 08, 2016 | Substantially Equivalent | Shofu Dental Corporation |
| K152118 | Zenostar MT, Zenostar Color Liquids | Dec 16, 2015 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K152451 | VINTAGE Art LF | Dec 11, 2015 | Substantially Equivalent | Shofu Dental Corporation |
| K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Dec 04, 2015 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K151894 | IPS Ivocolor | Oct 29, 2015 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K151875 | Pavati Zirconia | Oct 29, 2015 | Substantially Equivalent | Ccri, Inc. |
| K151723 | Rainbow Trans | Oct 28, 2015 | Substantially Equivalent | Genoss |
| K152066 | Luminesse Anterior Zirconia AT | Oct 21, 2015 | Substantially Equivalent | Talladium, Inc. |
| K151844 | Rainbow Shade | Oct 16, 2015 | Substantially Equivalent | Genoss |
| K151490 | PRETTAU ANTERIOR T0 | Oct 08, 2015 | Substantially Equivalent | Zirkonzahn GmbH |
| K152383 | Ceramill Zolid FX | Sep 21, 2015 | Substantially Equivalent | Emergo Europe Consulting |
| K150919 | ArgenZ Esthetic Plus | Jul 13, 2015 | Substantially Equivalent | The Argen Corporation |
| K143656 | StarCeram® Z-Nature, StarCeram® Z-Smile | Jul 09, 2015 | Substantially Equivalent | H.C. Starck Ceramics GmbH |
| K150872 | BruxZir Anterior Milling Blanks | Jul 02, 2015 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K143071 | Nacera Pearl | Jun 26, 2015 | Substantially Equivalent | Doceram Medical Ceramics GmbH |
| K140836 | ZIBONE ZIRCONIA BLOCKS | Jun 17, 2015 | Substantially Equivalent | Coho Technology Co., Ltd. |
| K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | Jun 15, 2015 | Substantially Equivalent | Talladium, Inc. |
| K140491 | TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS | May 20, 2015 | Substantially Equivalent | Tanaka Dental |
| K150056 | Luxisse+ | May 06, 2015 | Substantially Equivalent | Heany Industries, Inc. |
| K150196 | DD cubeX2 | Mar 26, 2015 | Substantially Equivalent | Dental Direkt GmbH |
| K143439 | KATANA Zirconia | Feb 27, 2015 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | Feb 11, 2015 | Substantially Equivalent | Dental Direkt of Amerika UG (Haftungsbeschraenkt) |
| K141400 | DCCERAM SYSTEM | Jan 28, 2015 | Substantially Equivalent | Ceramay GmbH & Co.Kg |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | Jan 05, 2015 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K142043 | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA | Dec 18, 2014 | Substantially Equivalent | Jensen Industries, Inc. |
| K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | Dec 18, 2014 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K140848 | LUMINESSE PORCELAIN SYSTEM | Dec 17, 2014 | Substantially Equivalent | Talladium, Inc. |
| K143330 | BruxZir Anterior | Dec 15, 2014 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) | Nov 06, 2014 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K132230 | ICE ZIRKON TRANSLUZENT | Nov 05, 2014 | Substantially Equivalent | Zirkonzahn Srl |
| K142670 | Vericore Zirconia Blanks | Oct 22, 2014 | Substantially Equivalent | Whip Mix Corporation |
| K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | Oct 22, 2014 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K141723 | UPCERA COLORING LIQUID (I AND II ) | Oct 22, 2014 | Substantially Equivalent | Liaoning Upcera Co., Ltd. |
| K141659 | PRISM ZIRCONIA, ST-98 | Oct 09, 2014 | Substantially Equivalent | A & D Dental Innovations |
| K140877 | VERICORE ZIRCONIA BLANKS | Sep 03, 2014 | Substantially Equivalent | Whip Mix Corp. |
| K141162 | ALL-CERAMIC ZIRCONIA BLOCK | Aug 27, 2014 | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. |
| K141788 | OBSIDIAN MILLING BLOCKS | Aug 20, 2014 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K140924 | STARCERAM | Jun 05, 2014 | Substantially Equivalent | H.C. Starck Ceramics GmbH |
| K140070 | LUXER SHADED ZIRCONIA | May 07, 2014 | Substantially Equivalent | Continental Dental Ceramics, Inc. |
| K133211 | ZIRTOUGH | Mar 20, 2014 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K130991 | NEXXZR(TM)T AND NEXXZR(TM)S | Feb 10, 2014 | Substantially Equivalent | Sagemax Bioceramics, Inc. |
| K132070 | VITA SUPRINITY(R) | Jan 31, 2014 | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. |
| K133213 | STARCERAM | Dec 05, 2013 | Substantially Equivalent | H.C. Starck Ceramics GmbH |
| K132102 | BECE CAD ZIRKON HT+ | Nov 12, 2013 | Substantially Equivalent | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO |
| K130198 | NEO DENTA ZIRCONIA | Oct 21, 2013 | Substantially Equivalent | Neo Group Limited |
| K131534 | KATANA ZIRCONIA | Oct 11, 2013 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K130654 | CRYSTAL ULTRA | Sep 24, 2013 | Substantially Equivalent | Dental Laboratory Milling Supplies, LLC (Dlms) |
| K130604 | UNIVERSAL PASTE STAINS AND GLAZE | Sep 12, 2013 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K131117 | ZIRMON SERIES | Jul 26, 2013 | Substantially Equivalent | Kuwotech Co., Ltd. |
| K130184 | ZENOLUX | May 24, 2013 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K130924 | BRUXZIR SHADED | May 16, 2013 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K122614 | VINTAGE MP PRESS OVER | May 16, 2013 | Substantially Equivalent | Shofu Dental Corporation |
| K123664 | INCORIS ZI | Apr 08, 2013 | Substantially Equivalent | Sirona Dental Systems GmbH |
| K123952 | CEREC BLOCS C IN | Mar 20, 2013 | Substantially Equivalent | Sirona Dental Systems GmbH |
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Feb 22, 2013 | Substantially Equivalent | Dentsply Intl. |
| K123680 | COPRANCOLOR | Feb 21, 2013 | Substantially Equivalent | White Peaks Dental Systems GmbH & Co. KG |
| K123613 | SYNSPAR ADVANCED | Feb 20, 2013 | Substantially Equivalent | Ardent, Inc. |
| K123545 | INCORIS TZI | Feb 01, 2013 | Substantially Equivalent | Sirona Dental Systems GmbH |
| K122269 | ENAMIC | Dec 13, 2012 | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. |
| K122972 | CDC ZIRCONIA BLANKS | Oct 24, 2012 | Substantially Equivalent | Continental Dental Ceramics, Inc. (Dba Continental |
| K121980 | ZIRPRIME | Oct 19, 2012 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K121359 | IPS 99 ONE AND IPS 99 CERAM | Jul 27, 2012 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K120134 | IPS E.MAX PRESS MULTI | Jun 25, 2012 | Substantially Equivalent | Ivoclar Vivadent, AG |
| K120852 | ZIRCONIA BLANKS (ZIRCOSTAR) | Jun 06, 2012 | Substantially Equivalent | Kerox, Ltd. |
| K113431 | CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA | Mar 30, 2012 | Substantially Equivalent | Bettini S.P.A. |
| K113575 | HILLA DIGITAL TRANSFERS | Mar 07, 2012 | Substantially Equivalent | Hilla Technologies, Inc. |
| K120011 | HEISENBERG EFFECT SHADES | Jan 13, 2012 | Substantially Equivalent | 3M Espe AG |
| K112806 | JENSEN ZIRCONIA | Dec 01, 2011 | Substantially Equivalent | Jensen Industries, Inc. |
| K112152 | CERCON HT | Nov 09, 2011 | Substantially Equivalent | Dentsply International, Inc. |
| K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR | Oct 17, 2011 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K111743 | THE INSYNC CERAMIC SYSTEM | Sep 14, 2011 | Substantially Equivalent | Jensen Industries, Inc. |
| K111573 | MONOBLOC BM SERIES | Aug 26, 2011 | Substantially Equivalent | Hass Corp. |
| K111383 | ZIRPRIME | Aug 12, 2011 | Substantially Equivalent | Noritake Co., Inc. |
| K110719 | ORIGIN ZIRCONIA | Aug 11, 2011 | Substantially Equivalent | B&D Dental Technologies |
| K111291 | AIDITE ZIRCONIA DENTAL CERAMICS | Jul 20, 2011 | Substantially Equivalent | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. |
| K111107 | SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE | Jun 30, 2011 | Substantially Equivalent | Noritake Co., Inc. |
| K111257 | HEISENBERG DYEING LIQUIDS | May 13, 2011 | Substantially Equivalent | 3M Espe AG |
| K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) | Apr 13, 2011 | Substantially Equivalent | Ivoclar Vivadent, Inc. |
| K103773 | ZENOFLEX DIMENSION | Mar 16, 2011 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K103494 | ZENOSTAR MAGIC GLAZE | Feb 16, 2011 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K100794 | FLUORCANASITE DENTAL CERAMIC | Jan 25, 2011 | Substantially Equivalent | Dr Sarah Pollington |
| K102305 | HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P | Dec 03, 2010 | Substantially Equivalent | Hass Corp. |
| K102538 | ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI | Oct 27, 2010 | Substantially Equivalent | Jyoti Ceramic Industries Private Limited |
| K101875 | BK BLANK MODEL 20,40,65,90 | Aug 23, 2010 | Substantially Equivalent | Bk Medent Co., Ltd. |
| K100512 | NOBELPROCERA IPS E.MAX CROWN | Aug 20, 2010 | Substantially Equivalent | Nobel Biocare AB |
| K102128 | VITABLOCS | Aug 11, 2010 | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. |
| K100781 | OBSIDIAN CERAMIC BLOCKS | Jun 21, 2010 | Substantially Equivalent | Prismatik Dentalcraft, Inc. |
| K100150 | CERAMICS2IN1 | May 25, 2010 | Substantially Equivalent | Biodenta Swiss AG |
| K100232 | LUMINESSE ZR BLANKS | May 21, 2010 | Substantially Equivalent | Talladium, Inc. |
| K100145 | A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 | Apr 13, 2010 | Substantially Equivalent | A&E Bioceramic Co., Ltd. |
| K100250 | XCERAM | Apr 08, 2010 | Substantially Equivalent | Xceramusa |
| K093571 | ZR DENTAL BLOCK | Mar 12, 2010 | Substantially Equivalent | Ams Co., Ltd. |
| K093559 | VINTAGE MP | Mar 03, 2010 | Substantially Equivalent | Shofu Dental Corp. |
| K093748 | DD BIO Z AND DD BIO Z - TRANSPA | Feb 24, 2010 | Substantially Equivalent | Dental Direkt of Amerika UG (Haftungsbeschraenkt) |
| K093560 | UPCERA ZIRCONIA BLANKS | Jan 28, 2010 | Substantially Equivalent | Shenyang Upcera Co., Ltd. |
| K093446 | VITA VMK MASTER | Dec 03, 2009 | Substantially Equivalent | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. |
| K092630 | ZIROX | Oct 22, 2009 | Substantially Equivalent | Zencera, Inc. |
| K092513 | RAINBOW BLOCK | Oct 09, 2009 | Substantially Equivalent | Genoss Co., Ltd. |
| K092020 | AADVA ZR COLORING LIQUID | Sep 29, 2009 | Substantially Equivalent | GC America, Inc. |
| K091826 | ELEGANT | Sep 25, 2009 | Substantially Equivalent | 3M Espe AG Dental Products |
| K090718 | BELLUS SHADING KIT | Sep 21, 2009 | Substantially Equivalent | 3M Espe AG Dental Products |
| K092496 | COPRAN ZR/ORIGIN YZ | Sep 18, 2009 | Substantially Equivalent | White Peaks Dental Systems GmbH & Co. KG |
| K091852 | BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 | Sep 10, 2009 | Substantially Equivalent | Refractron Technologies Corp. |
| K091706 | QUATTRO PORCELAIN SYSTEM | Aug 28, 2009 | Substantially Equivalent | Dentsply International, Inc. |
| K090434 | BECE PRESS | Jul 06, 2009 | Substantially Equivalent | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO |
| K091096 | NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 | Jun 18, 2009 | Substantially Equivalent | Dental Solutions, Inc. |
| K090684 | AVANTE LEUCITE BLOCKS | May 01, 2009 | Substantially Equivalent | Somerset Dental Products, Inc. |
| K090644 | VITABLOCS, MODEL VX55-**** | Mar 31, 2009 | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. |
| K082137 | DLMS-ZIRBLOCKS | Feb 10, 2009 | Substantially Equivalent | Dental Milling Laboratory Supplies (Dlms) |
| K083201 | ZMATCH BLOCK | Jan 26, 2009 | Substantially Equivalent | Dentaim Co., Ltd. |
| K082652 | BITTAR ZIRCONIA BLOCKS | Dec 30, 2008 | Substantially Equivalent | Bittar Zirconia Block, LLC |
| K082740 | GC AADVA ZR DISK | Nov 26, 2008 | Substantially Equivalent | GC America, Inc. |
| K082158 | DENSEO FAIRY | Oct 15, 2008 | Substantially Equivalent | Xpdent Corp |
| K081749 | AVANTE Z ZIRCONIA (AS)3 BLOCKS | Sep 30, 2008 | Substantially Equivalent | Pentron Ceramics, Inc. |
| K081850 | BISQUE ZIRCONIA BLANKS, TYPE BYZ | Sep 25, 2008 | Substantially Equivalent | Zircar Zirconia, Inc. |
| K082257 | ZENO AI ECO DISC | Sep 18, 2008 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K081200 | DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 | Aug 08, 2008 | Substantially Equivalent | Global Top, Inc. |
| K081263 | STARCERAM | Jul 01, 2008 | Substantially Equivalent | H.C. Starck Ceramics GmbH & Co.Kg |
| K080834 | VINTAGE ART | Jun 11, 2008 | Substantially Equivalent | Shofu Dental Corp. |
| K080146 | ZIRKONDENT | Jun 06, 2008 | Substantially Equivalent | Ergometa |
| K080479 | DENTAL CERAMIC | May 21, 2008 | Substantially Equivalent | Dmg USA, Inc. |
| K081253 | ZIRDENT CAD/CAM BLOCKS | May 15, 2008 | Substantially Equivalent | C5 Medical Werks, Inc. |
| K080195 | NACERA Z AND NACERA Z MEDIUM | Apr 28, 2008 | Substantially Equivalent | Doceram Medical Ceramics GmbH |
| K073314 | HEANY INDUSTRIES INC DENTAL XIRCONIA | Feb 21, 2008 | Substantially Equivalent | Heany Industries, Inc. |
| K073568 | PSL BIOZIR BLOCK | Feb 06, 2008 | Substantially Equivalent | P.S.L. International, Inc. |
| K073108 | ZENO ZR DISC | Nov 21, 2007 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K072569 | METOXIT CAM-BLANKS | Oct 31, 2007 | Substantially Equivalent | Metoxit AG |
| K071848 | IPS INLINE POM SYSTEM | Aug 30, 2007 | Substantially Equivalent | Ivoclar Vivadent, Inc. |
| K071010 | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS | Aug 24, 2007 | Substantially Equivalent | Schutz-Dental GmbH |
| K071410 | ARGEN PEARL BRAND ZIRCONIA | Aug 15, 2007 | Substantially Equivalent | The Argen Corporation |
| K071674 | GC-ZIRCONIA | Aug 09, 2007 | Substantially Equivalent | GC America, Inc. |
| K071201 | ZEO CE LIGHT & ZEO QUICK PORCELAIN | Jul 30, 2007 | Substantially Equivalent | Xpdent Corp |
| K070699 | AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN | Jun 29, 2007 | Substantially Equivalent | Pentron Ceramics, Inc. |
| K070772 | PRESSX ZR | Apr 30, 2007 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K070537 | ZIRBLOCK | Apr 30, 2007 | Substantially Equivalent | Cdl Technologies, Inc. |
| K063842 | CYRTINA SYSTEM | Apr 17, 2007 | Substantially Equivalent | Oratio B.V. |
| K070045 | ZIRBLANK-PS AND ZIRBLANK-FS | Mar 26, 2007 | Substantially Equivalent | Acucera, Inc. |
| K070114 | CREATION CP-ZI PORCELAIN | Mar 01, 2007 | Substantially Equivalent | Jensen Industries, Inc. |
| K063511 | CERAMILL ZI | Feb 02, 2007 | Substantially Equivalent | Amann Girrbach America, Inc. |
| K070019 | CARRARA VOLUMIA | Jan 26, 2007 | Substantially Equivalent | Dentsply Intl. |
| K062695 | SAGEMAX Z-BLANK | Oct 20, 2006 | Substantially Equivalent | Sagemax Bioceramics, Inc. |
| K061804 | ZERION ALPHA, ; ZERION BETA | Oct 06, 2006 | Substantially Equivalent | Etkon International GmbH |
| K061851 | ZIRKONZAHN ICE | Sep 29, 2006 | Substantially Equivalent | Zirkonzahn GmbH |
| K062509 | INCORIS ZI | Sep 12, 2006 | Substantially Equivalent | Sirona Dental Systems GmbH |
| K062506 | INCORIS AL | Sep 08, 2006 | Substantially Equivalent | Sirona Dental Systems GmbH |
| K062504 | CERAMAX | Sep 05, 2006 | Substantially Equivalent | Alphadent Co., Ltd. |
| K062389 | Z-BLOCK, MODELS 20/19, 40/19, 55/19 | Aug 21, 2006 | Substantially Equivalent | Foundation Milling Centre |
| K060860 | TURKOM-CERA | May 19, 2006 | Substantially Equivalent | Dental Suppliers of America, Inc. |
| K060441 | VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 | Apr 27, 2006 | Substantially Equivalent | Vident |
| K060104 | PRISMATIK CLINICAL ZIRCONIA | Mar 15, 2006 | Substantially Equivalent | Glidewell Laboratories |
| K060086 | FENIIIIIIX COLORATION KIT | Mar 03, 2006 | Substantially Equivalent | Dental Arte, Inc. |
| K053438 | GLASS CERAMICS | Jan 18, 2006 | Substantially Equivalent | 3M Espe AG Dental Products |
| K052710 | VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, | Jan 13, 2006 | Substantially Equivalent | Vident |
| K052304 | SUPER PORCELAIN EX-3 PRESS | Nov 23, 2005 | Substantially Equivalent | Noritake Co., Inc. |
| K052033 | VINTAGE ZR | Nov 18, 2005 | Substantially Equivalent | Shofu Dental Corp. |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent | Heraeus Kulzer, Inc. |
| K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD | Oct 14, 2005 | Substantially Equivalent | Ivoclar Vivadent, Inc. |
| K052130 | VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 | Aug 15, 2005 | Substantially Equivalent | Vident |
| K051249 | ZIROX | Jul 22, 2005 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K051462 | MODIFICATION TO: CERCON BASE | Jun 24, 2005 | Substantially Equivalent | Dentsply Intl. |
| K050903 | XAWEX G 100 | Jun 23, 2005 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K050920 | CZR PRESS LF STAINS | May 11, 2005 | Substantially Equivalent | Noritake Co., Inc. |
| K050838 | THE LF-P CERAMIC SYSTEM | May 04, 2005 | Substantially Equivalent | Jensen Industries, Inc. |
| K050362 | VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) | Mar 15, 2005 | Substantially Equivalent | Vident |
| K050144 | PRISMATIK CERAMIC | Mar 03, 2005 | Substantially Equivalent | Glidewell Laboratories |
| K050203 | ALLUX | Feb 14, 2005 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K050160 | KATANA ZIRCONIA | Feb 07, 2005 | Substantially Equivalent | Noritake Co., Inc. |
| K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA | Feb 01, 2005 | Substantially Equivalent | Nobel Biocare USA, LLC |
| K043472 | MEDIN TECH ZIRCONIA-CP10, SS1000 | Jan 18, 2005 | Substantially Equivalent | Medin Tech |
| K043468 | WILLI GELLER CREATION II PORCELAIN | Jan 12, 2005 | Substantially Equivalent | Jensen Int'L, Inc. |
| K043462 | CZR PRESS LF | Jan 11, 2005 | Substantially Equivalent | Noritake Co., Inc. |
| K043201 | WILLI GELLER CREATION ZI PORCELAIN | Jan 11, 2005 | Substantially Equivalent | Jensen Industries, Inc. |
| K043247 | DUCERA ALLCERAM | Dec 22, 2004 | Substantially Equivalent | Dentsply Intl. |
| K043221 | WILLI GELLER CREATION CP PORCELAIN | Dec 20, 2004 | Substantially Equivalent | Jensen Industries, Inc. |
| K042638 | RADIANCE PORCELAIN | Dec 17, 2004 | Substantially Equivalent | Aurident, Inc. |
| K042548 | CERASYS - ZR | Dec 03, 2004 | Substantially Equivalent | Cerasys, Inc. |
| K041707 | CERCON CERAM EXPRESS CERAMIC SYSTEM | Jul 30, 2004 | Substantially Equivalent | Dentsply Intl. |
| K041312 | NOBELRONDO DENTAL CERAMIC-ALUMINA | Jul 23, 2004 | Substantially Equivalent | Nobel Biocare Uas, Inc. |
| K041645 | DDS-ZR | Jul 09, 2004 | Substantially Equivalent | Charles Scharf |
| K041335 | PTM SYSTEM | Jun 16, 2004 | Substantially Equivalent | Dentsply International |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent | Heraeus Kulzer, Inc. |
| K040567 | GC INITIAL MC, AL AND LF | Apr 22, 2004 | Substantially Equivalent | GC America, Inc. |
| K040635 | CARRARA INTERACTION CERAMIC SYSTEM | Mar 30, 2004 | Substantially Equivalent | Dentsply Intl. |
| K040421 | DUCERAGOLD PORCELAINS | Mar 18, 2004 | Substantially Equivalent | Dentsply Intl. |
| K040420 | DUCERAM PLUS CERAMIC SYSTEM | Mar 18, 2004 | Substantially Equivalent | Dentsply Intl. |
| K032416 | VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN | Feb 05, 2004 | Substantially Equivalent | Shofu Dental Corp. |
| K033667 | CARRARA PRESS SYSTEM | Jan 23, 2004 | Substantially Equivalent | Dentsply Intl. |
| K024252 | MATCH MASTER LOW FUSION PORCELAIN | Jan 22, 2004 | Substantially Equivalent | Davis Schottlander & Davis, Ltd. |
| K031968 | CERABIEN ZR | Dec 22, 2003 | Substantially Equivalent | Noritake Co., Inc. |
| K033553 | PFZ PORCELAIN SYSTEM | Dec 02, 2003 | Substantially Equivalent | Dentsply Intl. |
| K033221 | KAVO EVEREST ZH-BLANK | Oct 28, 2003 | Substantially Equivalent | Kavo America Corporation |
| K033049 | CZR PRESS | Oct 24, 2003 | Substantially Equivalent | Noritake Co., Inc. |
| K032165 | VINTAGE AL | Sep 16, 2003 | Substantially Equivalent | Shofu Dental Corp. |
| K024250 | MATCH PRESS PRESSABLE CERAMIC | Aug 25, 2003 | Substantially Equivalent | Davis Schottlander & Davis, Ltd. |
| K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 | Jul 24, 2003 | Substantially Equivalent | Kavo America |
| K031326 | IMAGINE REFLEX | Jun 17, 2003 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES | May 02, 2003 | Substantially Equivalent | Kavo America |
| K030859 | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN | Mar 27, 2003 | Substantially Equivalent | Enamelite, LLC |
| K023327 | CYNOVAD ZIRKON | Dec 02, 2002 | Substantially Equivalent | Cynovad |
| K022996 | VITA IN-CERAM YZ CUBES FOR CEREC | Oct 09, 2002 | Substantially Equivalent | Vident |
| K022796 | CERCON CERAM S PORCELAIN | Sep 06, 2002 | Substantially Equivalent | Dentsply Intl. |
| K022408 | CEREC VITABLOCKS MK2 | Sep 06, 2002 | Substantially Equivalent | B.B.'S Prophy Shop |
| K020774 | IMAGINE H.E. PRESS DESIGN-CERAMIC | May 22, 2002 | Substantially Equivalent | Wieland Dental + Technik GmbH & Co. KG |
| K020269 | PROCERA ALLCERAM BRIDGE MATERIAL | Mar 27, 2002 | Substantially Equivalent | Procera Sandvik AB |
| K013230 | CERCON BASE | Oct 25, 2001 | Substantially Equivalent | Degussa - Ney Dental, Inc. |
| K011674 | DC - CRISTAL | Sep 04, 2001 | Substantially Equivalent | Austenal, Inc. |
| K012174 | ERIS LAYERING MATERIALS | Aug 27, 2001 | Substantially Equivalent | Ivoclar North America, Inc. |
| K012231 | AVANTE MICRO CRYSTAL SYSTEM | Aug 23, 2001 | Substantially Equivalent | Jeneric/Pentron, Inc. |
| K011333 | CERCON CERAM | Aug 20, 2001 | Substantially Equivalent | Degussa - Ney Dental, Inc. |
| K012156 | IMAGINE H.E. | Aug 16, 2001 | Substantially Equivalent | Wieland Edelmetalle GmbH & Co. |
| K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Jun 29, 2001 | Substantially Equivalent | Espe Dental AG |
| K011428 | TRICERAM | Jun 05, 2001 | Substantially Equivalent | Dentaurum, Inc. |
| K011425 | CARMEN | Jun 05, 2001 | Substantially Equivalent | Dentaurum, Inc. |
| K010630 | Y-TZP POWDER AND PROCERA ALLZIRKON | Apr 17, 2001 | Substantially Equivalent | Procera Sandvik, Inc. |
| K003373 | PROCAD ADD-ON | Nov 28, 2000 | Substantially Equivalent | Ivoclar North America, Inc. |
| K002993 | HERACERAM | Nov 16, 2000 | Substantially Equivalent | J.F. Jelenko & Co., Inc. |
| K002904 | WILLI GELLER CREATION AND LF PORCELAIN | Nov 06, 2000 | Substantially Equivalent | Jensen Industries, Inc. |
| K000983 | CERAMIX PORCELAIN SYSTEM | Aug 26, 2000 | Substantially Equivalent | C-Mix |
| K002041 | WILLI GELLER CREATION & AV PORCELAIN | Aug 16, 2000 | Substantially Equivalent | Jensen Industries, Inc. |
| K001815 | DC ZIRKON | Aug 10, 2000 | Substantially Equivalent | Austenal, Inc. |
| K001418 | ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S | Jul 05, 2000 | Substantially Equivalent | Procera Sandvik, Inc. |
| K000680 | VISION ESTHETIC PORCELAIN SYSTEM | May 25, 2000 | Substantially Equivalent | Midatlantic Division of Dentrex, Inc. |
| K000597 | VITA RESPONSE | May 17, 2000 | Substantially Equivalent | Vident |
| K994435 | OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS | Feb 10, 2000 | Substantially Equivalent | Jeneric/Pentron, Inc. |
| K992489 | 3M TR SYSTEM | Jan 11, 2000 | Substantially Equivalent | 3M Company |
| K993897 | CERGOGOLD | Jan 10, 2000 | Substantially Equivalent | Degussa - Ney Dental, Inc. |
| K993249 | OPC LOW WEAR OPAQUE PORCELAIN | Nov 29, 1999 | Substantially Equivalent | Jeneric/Pentron, Inc. |
| K984201 | DENZIR | Sep 29, 1999 | Substantially Equivalent | Dentronic AB |
| K992161 | CERANA | Sep 22, 1999 | Substantially Equivalent | Nordiska Dental AB |
| K992023 | GRAND CERAM | Sep 03, 1999 | Substantially Equivalent | Noritake Co., Inc. |
| K992024 | SUPER PORCELAIN TI-22 | Aug 27, 1999 | Substantially Equivalent | Noritake Co., Inc. |
| K991844 | PRO-GLASS | Jul 21, 1999 | Substantially Equivalent | Cad Cam Ventures |
| K990817 | IPS D.SIGN PORCELAIN | Apr 06, 1999 | Substantially Equivalent | Ivoclar North America, Inc. |
| K990790 | VISION PORCELAIN | Apr 02, 1999 | Substantially Equivalent | Servo Dental USA, Inc. |
| K990629 | SYMBIOCERAM | Mar 19, 1999 | Substantially Equivalent | Ney Dental, Inc. |
| K984427 | EXCELSIOR PORCELAIN SYSTEM | Mar 15, 1999 | Substantially Equivalent | Ney Dental, Inc. |
| K983470 | SUPER PORCELAIN STAIN- PURE WHITE | Dec 22, 1998 | Substantially Equivalent | Noritake Co., Inc. |
| K983453 | PROCERA ALLCERAM FUSING MATERIAL | Nov 18, 1998 | Substantially Equivalent | Nobel Biocare Uas, Inc. |
| K983247 | SUPER PORCELAIN ADDMATE | Nov 03, 1998 | Substantially Equivalent | Noritake Co., Inc. |
| K982766 | PASTE OPAQUE EX-3 | Oct 30, 1998 | Substantially Equivalent | Noritake Co., Inc. |
| K981490 | WILLI GELLER CREATION PORCELAIN | Oct 22, 1998 | Substantially Equivalent | Jensen Industries, Inc. |
| K982616 | IPS EMPRESS 2 | Sep 08, 1998 | Substantially Equivalent | Ivoclar North America, Inc. |
| K982377 | OPC LOWWEAR PORCELAIN | Aug 18, 1998 | Substantially Equivalent | Jeneric/Pentron, Inc. |
| K982129 | ANTAGON PORCELAIN | Aug 04, 1998 | Substantially Equivalent | European Dental Imports, Inc. |
| K982664 | VITA TITANIUM PORCELAIN | Aug 02, 1998 | Substantially Equivalent | Vident |
| K981524 | PRILANE | Jul 10, 1998 | Substantially Equivalent | Gresco Products, Inc. |
| K981000 | CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN | May 15, 1998 | Substantially Equivalent | European Dental Imports, Inc. |
| K980986 | PROCAD | May 11, 1998 | Substantially Equivalent | Ivoclar USA, Inc. |
| K972648 | SONICSYS INLAY | Oct 30, 1997 | Substantially Equivalent | Ivoclar North America, Inc. |
| K973247 | VINTAGE HALO | Oct 16, 1997 | Substantially Equivalent | Shofu Dental Corp. |
| K972827 | IPS EMPRESS COSMO INGOT | Sep 17, 1997 | Substantially Equivalent | Ivoclar North America, Inc. |
| K971869 | FINESSE ALL-CERAMIC SYSTEM | Sep 11, 1997 | Substantially Equivalent | Dentsply Intl. |
| K970941 | SLIPPERY GLASS | Apr 16, 1997 | Substantially Equivalent | Jeneric/Pentron, Inc. |
| K961291 | FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS | May 28, 1996 | Substantially Equivalent | Dentsply Intl. |
| K955070 | OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK | Dec 11, 1995 | Substantially Equivalent | Optimal Dental (Usa) |
| K954761 | FINESSE LOW-FUSING PORCELAIN SYSTEM | Nov 02, 1995 | Substantially Equivalent | Dentsply Intl. |
| K951582 | ULTRADENT PORCELAIN ETCH | May 10, 1995 | Substantially Equivalent | Ultradent Products, Inc. |
| K951183 | IN-CERAM SPINELL | May 02, 1995 | Substantially Equivalent | Vident |
| K944702 | PROCERA ALL-CERAMIC PORCELAIN | Dec 02, 1994 | Substantially Equivalent | Nobelpharma USA, Inc. |
| K943582 | SOFTWEAR PORCELAIN SYSTEM | Aug 29, 1994 | Substantially Equivalent | Dentsply Intl. |
| K934195 | VITA CELAY BLANKS AND VITA CELAY OPTIMIZER | Mar 18, 1994 | Substantially Equivalent | Vident |
| K940252 | FINESSE PORCELAIN SYSTEM | Mar 01, 1994 | Substantially Equivalent | Dentsply Intl. |
| K932039 | G-CERA ORBIT COLOUR COMMUNICATION SET | Jul 08, 1993 | Substantially Equivalent | GC America, Inc. |
| K915653 | KERAMAIL | Apr 08, 1993 | Substantially Equivalent | Wilde-USA, Inc. |
| K926238 | BISCO PORCELAIN ETCHING GEL | Mar 31, 1993 | Substantially Equivalent | Bisco, Inc. |
| K923717 | JELENKO PORCELAIN SYSTEM PVS PROCELAIN | Mar 16, 1993 | Substantially Equivalent | J.F. Jelenko & Co., Inc. |
| K921623 | VITADUR ALPHA PORCELAIN | Jul 02, 1992 | Substantially Equivalent | Vident |
| K921619 | DENTAL PORCELAIN | Jul 02, 1992 | Substantially Equivalent | Dentsply Intl. |
| K921479 | DUCERATIN/DUCERAM LFC DENTAL PORCELAIN | Jun 22, 1992 | Substantially Equivalent | Degussa AG |
| K913644 | VITA IN-CERAM | Jun 22, 1992 | Substantially Equivalent | Vident |
| K921474 | VITA OMEGA PORCELAIN | Jun 18, 1992 | Substantially Equivalent | Vident |
| K915543 | NEW OPAQUE PORCELAIN | Mar 19, 1992 | Substantially Equivalent | Dentsply Intl. |
| K913372 | IPS EMPRESS | Oct 25, 1991 | Substantially Equivalent | Ivoclar North America, Inc. |
| K905321 | PLATINUM FOIL, VARIOUS SIZES | Feb 26, 1991 | Substantially Equivalent | Ivoclar North America, Inc. |
| K905328 | WILL-CERAM BRUSHES, SUPER BRUSH KIT | Jan 17, 1991 | Substantially Equivalent | Ivoclar North America, Inc. |
| K901862 | VMK 68 AND VMK 68N DENTAL PORCELAIN KIT | Oct 10, 1990 | Substantially Equivalent | Vident |
| K902200 | VITA HI-CERAM | Oct 05, 1990 | Substantially Equivalent | Vident |
| K902105 | VITADUR-N DENTAL PORCELAIN KIT | Oct 05, 1990 | Substantially Equivalent | Vident |
| K901982 | VITACHROM-L DENTAL PORCELAIN KIT | Oct 05, 1990 | Substantially Equivalent | Vident |
| K895731 | DEN-MAT CERINATE PORCELAIN | Aug 03, 1990 | Substantially Equivalent | Den-Mat Corp. |
| K901261 | PV-CERAMIC, CERAMINIQUE | Jun 26, 1990 | Substantially Equivalent | Ivoclar North America, Inc. |
| K900393 | OPAQUE PORCELAIN | Apr 16, 1990 | Substantially Equivalent | Dentsply Intl. |
| K895888 | SILHOUETTE PORCELAIN | Apr 10, 1990 | Substantially Equivalent | Leach and Dillon Co., Inc. |
| K900209 | WILLI GELLER CERAMIC CREATION & SURPRISE | Apr 09, 1990 | Substantially Equivalent | Creation North America, Inc. |
| K895889 | SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN) | Apr 04, 1990 | Substantially Equivalent | Leach and Dillon Co., Inc. |
| K884356 | NORITAKE SUPER PORCELAIN EX-3 | Jan 10, 1989 | Substantially Equivalent | Noritake Co., Inc. |
| K864404 | PENTRON HIGH STRENGTH PORCELAIN | Nov 24, 1986 | Substantially Equivalent | Pentron Corp. |
| K855037 | TRU-COLOR | Mar 06, 1986 | Substantially Equivalent | Veritas Dental Co., Inc. |
| K854763 | CERAPEARL | Feb 21, 1986 | Substantially Equivalent | Kyocera International, Inc. |
| K853707 | DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES | Nov 19, 1985 | Substantially Equivalent | Dentsply Intl. |
| K853698 | SCOTCHPRIME CERAMIC PRIMER | Nov 14, 1985 | Substantially Equivalent | 3M Company |
| K852743 | PORCELAIN VENEER SYSTEM LABORATORY KIT | Jul 31, 1985 | Substantially Equivalent | The S. S. White Co. |
| K850821 | CERESTORE DENTIN PORCELAIN | Apr 08, 1985 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K840873 | CRYSTAR PORCELAIN MARGIN POWDER/LIQUID | Apr 25, 1984 | Substantially Equivalent | Shofu Dental Corp. |
| K834497 | SHOFU PORCELAIN STAIN | Mar 06, 1984 | Substantially Equivalent | Shofu Dental Corp. |
| K833643 | CRYSTAR PORCELAIN | Dec 29, 1983 | Substantially Equivalent | Shofu Dental Corp. |
| K832286 | CERESTORE CORE MATERIAL | Sep 26, 1983 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K831483 | SAVE-A-BAKE PORCELAIN POLISH | Jul 28, 1983 | Substantially Equivalent | Denpac Corp. |
| K830955 | DENTAL CERAMIC FOR FABRICATION OF CROWN | May 09, 1983 | Substantially Equivalent | Dentsply Intl. |
| K830553 | DENTAL PORCELAIN POWDER | Apr 06, 1983 | Substantially Equivalent | Dentsply Intl. |
| K823378 | CERA COLOR | Dec 03, 1982 | Substantially Equivalent | Cer-Met, Inc. |
| K823377 | CERA 8 | Dec 03, 1982 | Substantially Equivalent | Cer-Met, Inc. |
| K820057 | LUXOR PORCELAIN | Mar 02, 1982 | Substantially Equivalent | Jeneric Ind. |
| K810822 | DENTAL PORCELAIN POWDER | Apr 21, 1981 | Substantially Equivalent | Coors Biomedical Co. |
| K810096 | PORCELAIN POWDER FOR CLINICAL USE | Mar 04, 1981 | Substantially Equivalent | Dentsply Intl. |
| K803310 | CERAMCO PORCELAIN | Jan 14, 1981 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K802235 | MICRO-BOND HI-LIFE PROCELAIN & VIVERE | Sep 26, 1980 | Substantially Equivalent | Howmedica Corp. |
| K771887 | ACCU-STAIN | Nov 14, 1977 | Substantially Equivalent | Williams Gold Refining Co., Inc. |
| K771886 | ACCU-PAQUE | Nov 14, 1977 | Substantially Equivalent | Williams Gold Refining Co., Inc. |
| K770932 | GERAMCO LOW TEMP GLAZE | Jun 03, 1977 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
FEI Numbers
This FDA classification entry is associated with 158 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 158 registration numbers. Click on an entry to view related FDA registrations.