FDA Registration
Active
🇺🇸 United States
PAC-DENT INC.
Reg #: 2086043
·
FEI: 3000719964
·
Expires 2026
Products
83
Proprietary Names
74
Establishment Types
3
Classifications
83
Registration Details
- Registration Name
- PAC-DENT INC.
- Registration Number
- 2086043
- FEI Number
- 3000719964
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 670 Endeavor Cir
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030603
Owner / Operator
- Firm Name
- Pac-Dent Inc.
- Operator Number
- 10056434
- Address
- 670 Endeavor Cir
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- Nikki Huynh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2017-12-21 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-07-24 |
| Device, Heat-Sealing | KSD | Class 1 | Hematology | No | 2017-12-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2019-01-25 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2017-12-11 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-06-25 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2024-06-25 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2022-09-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-02 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2017-12-21 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2017-12-21 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2017-12-21 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2021-05-04 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-01 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2017-12-14 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2017-12-14 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2017-12-14 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-02-17 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2017-12-14 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2017-12-21 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2017-12-14 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2025-09-04 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2017-12-14 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-12-08 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-09-16 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2017-12-21 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2017-12-29 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2023-09-20 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2018-06-22 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2024-06-25 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2020-12-15 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2017-12-14 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2018-09-13 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2017-12-21 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2017-12-11 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2023-04-14 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2017-12-11 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2017-12-21 |
| Material, Impression | ELW | Class 2 | Dental | No | 2017-12-14 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2017-12-14 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2017-12-14 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2017-12-11 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2017-12-14 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2017-12-21 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2022-04-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-12-14 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2017-12-11 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2022-10-20 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2018-09-13 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2017-12-14 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2024-06-27 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2024-06-27 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2018-10-29 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2017-12-21 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2017-12-21 |
| Reliner, Denture, Over The Counter | EBP | Class 2 | Dental | No | 2024-05-07 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2017-12-21 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2017-12-08 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2017-12-11 |
| Collimator, X-Ray | EHB | Class 1 | Dental | No | 2017-12-11 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2017-12-21 |
| Aligner, Beam, X-Ray | EHA | Class 1 | Dental | No | 2022-08-25 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2017-12-14 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2017-12-14 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2017-12-14 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2017-12-14 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2017-12-08 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2019-01-17 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2017-12-14 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2022-12-27 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2017-12-11 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2017-12-14 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2024-08-26 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2022-04-27 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2017-12-11 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2017-12-14 |
Proprietary Names
Pac-Dent Disposable Tray, Tooth Whitening
Pac-Dent SG
JS Dental
ProAngle
ProMate
Freestyle Pro
ProMateEZ-Q Quick Disconnect Coupler
AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct
AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct
ProMate EZ-Q Quick Disconnect Hygiene Handpiece
ACCLEAN ERGO PROPHY ANGLE LF
AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct
AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct
AntiSplatr Disposable Prophy Angles
ProMate EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler
Rodin 3D Resin Try-In
Isolation clothing
Armor Premium Disposable Plastic Non-Surgical Isolation Gowns
Disposable Protective Coverall Safety Suit
Disposable Plastic Isolation Gown
Disposable Button-Up Isolation Gown
Reusable Non-Surgical Isolation Gowns
Disposable Non-Woven Isolation Gowns
Digital Thermometer
Rodin Luting Cement
Rodin Envision veneer cement
PJ-01 ProJect Composite Dispensing Gun
Rodin 3D Ceramic Nanohybrid Resin
Rodin Sculpture 2
RapidCeram
iMatrix Clear
Rodin InteCem Intermediate Restorative Material
Rodin 3D Resin Clear Bite Spl
Rodin TruModel
FINGER SPREADER
LENTULO PSTE FILL
SPIRAL PASTE FILL
G-FILE METAL
Bur Block Magnetic
PacBond One
OptiComp
Promin Dental Desensitizing Gel
341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml
341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case
341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case
COMPOSITE SPATULAS PLASTIC
iBrite Teeth Whitening Gel
PacTemp Automix Releasing Agent
PacTemp Automix NE Releasing Agent
EzAim X-Ray Positioning System
PacEndo Vital Ice 360 Green 1 bottle 6oz
PacEndo Vital Ice 360 Green 12 bottles per case
EtchPro Etching Gel
Medidenta High Speed Handpieces
Rodin 3D Resin Denture Base
EasyProp
Endo Aid Kit
Endo organizer
FINGER PLUGGER
Air Techniques
Pac-Dent Barrier Sleeve, Cover It Barrier Film
UNIVERSAL CURING LIGHT SHIELD
PSP Barrier Envelopes
Pinnacle Sleeves, Covers, Sheaths, Cover-All, Allrap Protective Barriers
131116 EzAim ComforTab Adhesive Sensor Holder Anterior Blue, 50/pk
131118 EzAim ComforTab Adhesive Sensor Holder Bitewing Red, 50/pk
131117 EzAim Individually Cut Adhesive Sensor Holder Anterior White, 50/pk
131118 EzAim Individually Cut Adhesive Sensor Holder Bitewing Red, 50/pk
131117 EzAim ComforTab Adhesive Sensor Holder Anterior White, 50/pk
131120 EzAim Individually Cut Adhesive Sensor Holder Posterior Yellow, 50/pk
131119 EzAim Individually Cut Adhesive Sensor Holder Bitewing Blue, 50/pk
131116 EzAim Individually Cut Adhesive Sensor Holder Anterior Blue, 50/pk
131119 EzAim ComforTab Adhesive Sensor Holder Bitewing Blue, 50/pk
131120 EzAim ComforTab Adhesive Sensor Holder Posterior Yellow, 50/pk
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device