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Duralay Temporary Crown & Brdige
EUDAMEDClass IIa (EU MDR)
Ref Duralay Temporary Crown & Bridge 2oz Powder Shade 65Model Duralay Temporary Crown & Bridge
Identity
- Trade Name
- Duralay Temporary Crown & Brdige EUDAMED
- Device Name
- Duralay Temporary Crown & Bridge Package EUDAMED
- Model / Reference
- Duralay Temporary Crown & Bridge EUDAMEDDuralay Temporary Crown & Bridge 2oz Powder Shade 65 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D947250565 EUDAMED
- Basic UDI-DI
- ++D947DuralayTCBK97D EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Duralay Temporary Crown & Brdige by Reliance Dental Manufacturing — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D947DuralayTCBK97D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
- EUDAMED SRN
- US-MF-000041470
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (1)
- EUDAMED 7757a276-71ed-4114-b4ff-2052b4bcf62d 61 fields · synced Jul 11, 2026