Identity
- Trade Name
- BEAUTIFIL II ENAMEL FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- BEAUTIFIL II ENAMEL AM 2.5G FDA UDI
- Model / Reference
- Y2253 FDA UDI
- Description
- BEAUTIFIL II ENAMEL AM 2.5G FDA UDI
Identifiers
- Catalog Number
- Y2253 FDA UDI
- Primary DI / UDI-DI
- E235Y22530 FDA UDI
- 510(k) Number
- FDA Product Code
- EBF FDA 510(k)FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)FDA UDI
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
No
FDA UDI
BEAUTIFIL II Enamel by Shofu Dental Corporation — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151699 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corporation
Sources (2)
- FDA 510(k) K151699 24 fields · synced Jun 19, 2026
- FDA UDI 342e4c29-9cb1-42bd-90c2-66ebf617d91e 36 fields · synced May 27, 2026