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Bio-C Sealer
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 3822Model Bioceramics
Identity
- Trade Name
- BIO-C SEALER EUDAMEDFDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER 0.5 g FDA UDI
- Model / Reference
- Bioceramics EUDAMED3822 EUDAMEDBIO-C SEALER 0.5 g FDA UDI
- Description
- Ready-to-use Bioceramic Root Canal Sealer - BIO-C SEALER 0.5 g FDA UDI
Identifiers
- Catalog Number
- 3822 FDA UDI
- Primary DI / UDI-DI
- 07898078659816 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 Sealer by Angelus Indústria De Produtos Odontológicos S/A — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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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 | K172701 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 807865BIOCERAMICSQN | Class IIa | Active |
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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 ec313e61-4aa0-4920-8dca-a34fd6297d7f 61 fields · synced Jul 8, 2026
- FDA UDI a43f22f8-d81f-454e-827e-f3a494ea7674 35 fields · synced May 29, 2026
- FDA 510(k) K172701 1 fields · synced May 18, 2026