Identity
- Trade Name
- Enamel Pro® Prophy Paste FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free FDA UDI
- Model / Reference
- 9007613 FDA UDI
- Description
- Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783005196 FDA UDI
- 510(k) Number
- K062166 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dentifrice
Enamel Pro® Prophy Paste by Premier Dental Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dentifrice.
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- Topex® Prophy Paste — Dentsply International · Class I
- Omni — Keystone Industries · Class I
- Disposable Prophy Angles, 105° Contra Angle Clear, Ribbed and Webbed — Premium Plus (Dongguan) Limited · Class IIa
- Dental City — ICP, INC. · Class I
- Blasting Powder — Bioclear Matrix Systems, LLC · Class I
- Prophy Brush — Huanghua Promisee Dental Co.Ltd. · Class I
- Disposable Prophy Cups, CA Plastic Shank, Ribbed & Webbed Standard — Premium Plus (Dongguan) Limited · Class IIa
Cleared under the same submission
K062166 also covers:
- PractiPro Mint TCP Prophy Paste Coarse — PRACTICON, INC.
- PractiPro Mint TCP Prophy Paste Medium — PRACTICON, INC.
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
- Enamel Pro® Prophy Paste — PREMIER DENTAL PRODUCTS COMPANY
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (1)
- FDA UDI 257bf33e-520a-4ac2-ae91-5a469fdef5fe 34 fields · synced Jun 8, 2026