Identity
- Trade Name
- BIO-C REPAIR FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 2 g FDA UDI
- Model / Reference
- BIO-C REPAIR 2 g FDA UDI
- Description
- Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 2 g FDA UDI
Identifiers
- Catalog Number
- 3863 FDA UDI
- Primary DI / UDI-DI
- 07898078658864 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- 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
Category: Endodontic filling/sealing material
Bio-C Repair by Angelus Industria de Produtos Odontologicos S A — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Angelus Industria de Produtos Odontologicos S A
Sources (1)
- FDA UDI b7c88b69-38ea-4dc3-ad1a-fd53077d3edb 35 fields · synced Jun 8, 2026