Identity
- Trade Name
- Duraflex EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Thermoplastic denture base resin EUDAMEDDark Pink, Small Cartridge 6pk Thermoplastic Resin Material FDA UDI
- Model / Reference
- DF-DPNK-SM-6pk EUDAMEDFDA UDI
- Description
- Dark Pink, Small Cartridge 6pk Thermoplastic Resin Material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326102057 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423261ThermoplasticDR5S EUDAMED
- 510(k) Number
- K063626 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q0102050102 DENTAL REBASING RESINS EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- France 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
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
No
FDA UDI
Duraflex by The Myerson Company Limited — 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 | 08423261ThermoplasticDR5S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Myerson Company Limited
- EUDAMED SRN
- TT-MF-000045141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b7f4edba-dd70-4bce-aed3-2b46b567a6e0 61 fields · synced May 30, 2026
- FDA UDI ff2d378f-44d0-4843-97a6-4985734a61e6 36 fields · synced May 30, 2026