← Back to catalogue
Bio-C Repair
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 3861Model Bioceramics
Identity
- Trade Name
- BIO-C REPAIR EUDAMEDFDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 0.5 g FDA UDI
- Model / Reference
- Bioceramics EUDAMED3861 EUDAMEDBIO-C REPAIR 0.5 g FDA UDI
- Description
- Ready-to-use Bioceramic Reparative Material - BIO-C REPAIR 0.5 g FDA UDI
Identifiers
- Catalog Number
- 3861 FDA UDI
- Primary DI / UDI-DI
- 07898078659847 EUDAMEDFDA UDI
- Basic UDI-DI
- 807865BIOCERAMICSQN EUDAMED
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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: Calcium hydroxide dental cement
Bio-C Repair by Angelus Indústria De Produtos Odontológicos S/A — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Similar devices
Also classified as Calcium hydroxide dental cement.
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- AxioPro ART — Axiodent Inc. · Class II
- Calcimol LC — VOCO GmbH · Class II
- ADSEAL — Meta Biomed Co., Ltd. · Class IIa
- Cerafill RCS — PREVEST DENPRO LIMITED · Class II
- Endoseal — PREVEST DENPRO LIMITED · Class II
- Cerafill Putty — PREVEST DENPRO LIMITED · Class IIa
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180185 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 807865BIOCERAMICSQN | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Angelus Indústria De Produtos Odontológicos S/A
- EUDAMED SRN
- BR-MF-000010255
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 5739f9db-fe07-4cd1-a28a-2608125a0390 61 fields · synced Jul 11, 2026
- FDA UDI b37efc93-19ae-4785-885d-c1a29112509d 35 fields · synced May 30, 2026
- FDA 510(k) K180185 1 fields · synced May 18, 2026