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Duralay
EUDAMEDFDA UDIClass I (EU MDR)
Ref Duralay Standard Package RedModel Duralay
Identity
- Trade Name
- Duralay EUDAMEDDURALAY - Red FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- Duralay EUDAMEDINLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID (56 GR POWDER / 60 ML LIQUID) FDA UDI
- Model / Reference
- Duralay EUDAMEDDuralay Standard Package Red EUDAMED2244 FDA UDI
- Description
- INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID (56 GR POWDER / 60 ML LIQUID) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9472244 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D947DuralayB3 EUDAMED
- FDA Product Code
- EBH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental impression tray material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Duralay by Reliance Dental Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++D947DuralayB3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
- EUDAMED SRN
- US-MF-000041470
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (2)
- EUDAMED 830da7ef-9f46-4e66-9bd5-44f75241854f 61 fields · synced May 30, 2026
- FDA UDI bcbd9dab-12a9-4198-b497-95a9fe3d55ce 34 fields · synced May 30, 2026