Identity
- Trade Name
- Enamel Pro® Prophy Paste Grape-Fine (Box of 200) EUDAMEDEnamel Pro® Prophy Paste FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Enamel Pro® Prophy Paste EUDAMEDEnamel Pro® Prophy Paste Grape-Fine FDA UDI
- Model / Reference
- 9007610 EUDAMEDFDA UDI
- Description
- Enamel Pro® Prophy Paste Grape-Fine FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00348783005295 EUDAMEDFDA UDI
- Basic UDI-DI
- 00348783EnamelProPPasteJ3 EUDAMED
- 510(k) Number
- K062166 FDA UDI
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q010502 DENTAL POLISHING CUPS, SINGLE-USE EUDAMED
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Premier Dental Products Company
Sources (2)
- FDA UDI 6c5594ab-9fa6-4679-a192-01d51323cc67 34 fields · synced Jul 23, 2026
- EUDAMED 01d9306f-5547-4227-b88c-292d26908f6b 61 fields · synced Jul 23, 2026