FDA Registration
Active
🇺🇸 United States
Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Biomet 3i Certain 4.1 mm
Reg #: 3011649314
·
FEI: 3011649314
·
Expires 2025
Products
1
Proprietary Names
191
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PRISMATIK DENTALCRAFT, INC.
- Registration Number
- 3011649314
- FEI Number
- 3011649314
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2144 Michelson Drive
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121688
Owner / Operator
- Firm Name
- PRISMATIK DENTALCRAFT, INC.
- Operator Number
- 10043585
- Address
- 2144 Michelson Drive
- City
- Irvine
- State
- CA
- Postal Code
- 92612
- Country
- US
- Correspondent
- Michelle Gallup
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-03-05 |
Proprietary Names
Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level RC
Inclusive Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 5 mm
Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 4.5 Platform x 3 mmH
Inclusive 30degree Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive Tapered Implant 30degree Multi-Unit Abut. 3.5 mmP x 3 mmH
Inclusive Angled Multi-Unit Abutment Screw
Inclusive Multi-Unit Abut. 2 mmH compatible with: MegaGen AnyrRdge Implant System
Inclusive 17 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 5 mm
Inclusive 17degree Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive Multi-Unit Abutment 1 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive Tapered Implant Multi-Unit Abutment, 3.5 Platform x 2 mmH
Inclusive Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 3.4 mm
Inclusvie 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace WP
Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 4.5 Platform x 5 mmH
Inclusive Tapered Implant 17degree Multi-Unit Abut. 3.5 mmP x 3 mmH
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive 17degree Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Standard
Iinclusive 30 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive Angled Multi-Unit Abutment Screw compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive 17 Degree Multi-Unit Abutment, 2 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 5 mm
Inclusive Multi-Unit Abutment 5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelReplace NP
Inclusive Multi-Unit Abutment 1 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 3.4 mm
Inclusive Angled Multi-Unit Abutment Screw compatible with: Camlog Screw-Line 3.8/4.3 mm
Inclusive Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive Tapered Implant 17degree Multi-Unit Abut. 4.5 mmP x 5 mmH
Inclusive 17degree Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Prosthetic Screw 48" Hex
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive 30 Degree Multi-Unit Abutment, 5 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level NC
Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level NC
Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelActive RP
Inclusive Multi-Unit Abutment 1 mmH for CAMLOG SCREW-LINE 5 mm
Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 2 mmH
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Hiossen HG System Standard
Inclusive 17 Degree Multi-Unit Abutment, 2 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Tapered Implant 17degree Multi-Unit Abut. 3.5 mmP x 2 mmH
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive 30degree Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Mini
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace NP
Inclusive Tapered Implant 30 Degree Multi-Unit Abutment, 3.5 Platform x 3 mmH
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace WP
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Hiossen HG System Standard
Inclusive 30 degree Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 5 mmH
Inclusive Multi-Unit Abutment. 4 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive Multi-Unit Abut. 5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 5 mm
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level NC
Inclusive 30degree Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace WP
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level RC
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level RC
Inclusive Multi-Unit Abutment 2 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 4.5 Platform x 2 mmH
Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 1 mmH
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive 30degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard
Inclusive 30degree Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Hiossen HG System Standard
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Hiossen HG System Mini
Inclusive Tapered Implant 17degree Multi-Unit Abut. 4.5 mmP x 2 mmH
Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelActive NP
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Incuisive 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Multi-Unit Prosthetic Screw SCS
Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Tapered Implant 30 Degree Multi-Unit Abutment, 4.5 Platform x 3 mmH
Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusvie 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace NP
Inclusive 17degree Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive Tapered Implant 30degree Multi-Unit Abut. 4.5 mmP x 3 mmH
Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace NP
Inclusive 30degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive Multi-Unit Abutment 1 mmH compatible with: Straumann Tissue Level RN synOcta
Inclusive Multi-Unit Titanium Temporary with Prosthetic Screw 50 Hex
Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare Branemark RP
Inclusive 30 degree Multi-Unit Abutment 5 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 3.5 Platform x 2 mmH
Inclusive 17 Degree Multi-Unit Abutment, 5 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive Multi-Unit Abutment 5 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level RC
Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 3.5 Platform x 3 mmH
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level NC
Inclusive Tapered Implant 17degree Multi-Unit Abut. 4.5 mmP x 3 mmH
Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive Multi-Unit Temporary Healing Cap with Prosthetic Screw 50 Hex
Inclusive Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Hiossen HG System Standard
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Hiossen HG System Mini
Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level RC
Inclusive 17 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive Angled Multi-Unit Abutment Screw compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm
Inclusive Multi-Unit Abut. 4 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Abutment 5 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive 17degree Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Mini
Inclusive Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare NobelReplace NP
Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive Tapered Implant Multi-Unit Abutment, 3.5 Platform x 1 mmH
Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive Tapered Implant 30 Degree Multi-Unit Abutment, 4.5 Platform x 5 mmH
Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 3.4 mm
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Bone Level RC
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4
Inclusive Angled Multi-Unit Abutment Screw compatible with: Straumann Bone Level NC/RC
Inclusive Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Hiossen HG System Mini
Inclusive Tapered Implant Multi-Unit Abutment 3.5 mmP x 5 mmH
Inclusive 17 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive 30degree Multi-Unit Abut. 6.5 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelReplace RP
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive Multi-Unit Abutment 1 mmH compatible with: Biomet 3i Certain 3.4 mm
Inclusive Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace RP
Inclusive Multi-Unit Abut. 3 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Straumann Bone Level RC
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Tissue Level WN synOcta
Inclusive 17degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard
Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 3.4 mm
Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 3 mmH
Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Straumann Bone Level RC
Inclusive 30 degree Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive 30 Degree Multi-Unit Abutment, 5 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm
Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace WP
Inclusive Multi-Unit Abutment 3 mmH compatible with: MegaGen AnyRidge Implant System
Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare NobelReplace WP
Inclusive 17 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive NP
Inclusive Multi-Unit Temporary Healing Cap
Inclusive Tapered Implant Multi-Unit Abutment 3.5 mmP x 3 mmH
Inclusive Multi-Unit Abutment 1 mmH for CAMLOG SCREW-LINE 3.8 mm
Inclusive 17degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini
Inclusive Tapered Implant 30degree Multi-Unit Abut. 4.5 mmP x 5 mmH
Inclusive Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 4.1 mm
Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 5 mm
Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive Multi-Unit Abutment Screw
Inclusive Angled Multi-Unit Abutment Screw compatible with: Dentsply Implant Ankylos C/X
Inclusive Angled Multi-Unit Abutment Screw compatible with: Dentsply Implants Astra Tech Implant System 4.5/5
Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive RP
Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare Branemark System RP
Inclusive Multi-Unit Prosthetic Screw 50" Hex
Inclusive Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 5 mm
Inclusive 30degree Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Standard
Inclusive 30 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 4.3 mm
Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace NP
Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Bone Level NC
Inclusive Multi-Unit Abutment 1 mmH compatible with: Biomet 3i Certain 5 mm
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198