Identity
- Trade Name
- RE-FINE BRIGHT FDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Model / Reference
- 17L FDA UDI
Identifiers
- Primary DI / UDI-DI
- D080XXRFBX17LXXXXX0 FDA UDI
- 510(k) Number
- K131036 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental prosthesis restorative material, unfilled resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
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
Category: Dental prosthesis restorative material, unfilled resin
Re-Fine Bright by Yamahachi Dental Mfg., Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131036 also covers:
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- ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
Sources (1)
- FDA UDI 86f3cfbc-51cc-45d9-a67b-8659b0eb2225 33 fields · synced May 30, 2026