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EdgeUtopia BioCeramic Sealer 2 g
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 38231Model Bioceramics
Identity
- Trade Name
- EdgeUtopia BioCeramic Sealer 2 g EUDAMEDEdgeUtopia Bioceramic Sealer FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- Ready to use endodontic bioceramic obturator cement. FDA UDI
- Model / Reference
- Bioceramics EUDAMED38231 EUDAMEDEdgeUtopia Bioceramic Sealer 2 g FDA UDI
- Description
- Ready to use endodontic bioceramic obturator cement. FDA UDI
Identifiers
- Catalog Number
- 38231 FDA UDI
- Primary DI / UDI-DI
- 07898078654644 EUDAMEDFDA UDI
- Basic UDI-DI
- 807865BIOCERAMICSQN EUDAMED
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
EdgeUtopia BioCeramic Sealer 2 g by Angelus Indústria De Produtos Odontológicos S/A — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 807865BIOCERAMICSQN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 4d2c55d9-67a9-46ea-969c-897ca307de1c 61 fields · synced Jun 19, 2026
- FDA UDI 5c78780e-184a-4251-b982-1a954b82999d 35 fields · synced May 30, 2026