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Duralay Temporary Crown & Bridge
EUDAMEDClass IIa (EU MDR)
Ref Duralay Temporary Crown & Bridge Powder Shade 62Model Duralay Temporary Crown & Bridge Ref Temporary Crown & Bridge 2oz Powder Shade 62Ref Temporary Crown & Bridge 2oz Powder Shade 69Ref Temporary Crown & Bridge 8oz Powder Shade 77
Identity
- Trade Name
- Duralay Temporary Crown & Bridge EUDAMED
- Device Name
- Duralay Temporary Crown & Bridge Package EUDAMED
- Model / Reference
- Duralay Temporary Crown & Bridge EUDAMEDDuralay Temporary Crown & Bridge Powder Shade 62 EUDAMEDTemporary Crown & Bridge 2oz Powder Shade 62 EUDAMEDTemporary Crown & Bridge 2oz Powder Shade 69 EUDAMEDTemporary Crown & Bridge 8oz Powder Shade 77 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D947250562 EUDAMEDD947250862 EUDAMEDD947250569 EUDAMEDD947250877 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 & Bridge 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 (4)
- EUDAMED ece670d5-facd-4a4a-b523-07f473d12bf4 61 fields · synced Jul 29, 2026
- EUDAMED ae58ddac-5490-4187-a81e-1f07b3433ad1 61 fields · synced May 17, 2026
- EUDAMED 93233227-d4ca-42fc-9d2d-522af5bcadce 61 fields · synced May 18, 2026
- EUDAMED 8b0f0c7a-4a5e-457a-9330-0543d3975f23 61 fields · synced May 19, 2026