Identity
- Trade Name
- RE-FINE BRIGHT EUDAMEDFDA UDI
- Generic Name
- Dental prosthesis restorative material, unfilled resin FDA UDI
- Model / Reference
- 250G,PINK EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- XXRFB250GXXPNK EUDAMEDD080XXRFB250GXXPNK0 FDA UDI
- Basic UDI-DI
- B-XXRFB250GXXPNK EUDAMED
- 510(k) Number
- K131036 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
- GMDN Term
- Dental prosthesis restorative material, unfilled resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Dental appliance fabrication material, resin
Re-Fine Bright by Yamahachi Dental Mfg., Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-XXRFB250GXXPNK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
- EUDAMED SRN
- JP-MF-000024849
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 971a3276-cd12-4c01-b5ff-7a643d234a3f 61 fields · synced Jun 8, 2026
- FDA UDI 573d13d4-e37f-4b88-9ba7-a2890d5868c1 33 fields · synced May 30, 2026