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Dentac
EUDAMEDClass IIa (EU MDR)
Ref DC11113Model CERASEAL
by Oncu Dental Tibbi Malzeme Sanayi Ve Dis Ticaret Anonim Sirketi
Identity
- Trade Name
- DENTAC EUDAMED
- Device Name
- DENTAC BIOSERRA BIOSECERAMIC ROOT CHANNEL SEALING MATERIAL EUDAMED
- Model / Reference
- CERASEAL EUDAMEDDC11113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681942650786 EUDAMED
- Basic UDI-DI
- B-08681942650786 EUDAMED
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Calcium hydroxide dental cement
Dentac by Oncu Dental Tibbi Malzeme Sanayi Ve Dis Ticaret Anonim Sirketi — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08681942650786 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000022981
Sources (1)
- EUDAMED 8e217416-8871-468c-815b-47707246d28f 61 fields · synced Jun 18, 2026