Identity
- Trade Name
- PractiPro Mint TCP Prophy Paste Coarse FDA UDI
- Generic Name
- Dental bleaching agent FDA UDI
- Device Name
- Coarse Grit Mint Prophy Paste with TCP FDA UDI
- Model / Reference
- 7159810 coa FDA UDI
- Description
- Coarse Grit Mint Prophy Paste with TCP FDA UDI
Identifiers
- Catalog Number
- 7159810 coa FDA UDI
- Primary DI / UDI-DI
- 00723896021262 FDA UDI
- 510(k) Number
- K062166 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Dental bleaching agent 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Dental bleaching agent
PractiPro Mint TCP Prophy Paste Coarse by Practicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental bleaching agent.
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Cleared under the same submission
K062166 also covers:
- 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
- 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 |
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Manufacturer
- Manufacturer
- Practicon, Inc.
Sources (1)
- FDA UDI fce73b8a-72e3-47a6-a08d-4c6bcf207916 35 fields · synced Jun 8, 2026