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DuraCetal
EUDAMEDFDA UDIClass I (EU MDR)
Ref DC-DISC-P1-9825Ref DC-DISC-G2-9820Ref DC-DISC-A1-9820Ref DC-DISC-A1-9825Ref DC-DISC-P1-9815Ref DC-DISC-G2-9825Ref DC-DISC-A2-9820Ref DC-DISC-A5-9825Ref DC-DISC-A5-9820Ref DC-DISC-A2-9825Ref DC-DISC-B1-9825Ref DC-B10-12.5kg
Identity
- Trade Name
- DuraCetal EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Thermoplastic denture base resin EUDAMEDShade B1-12.5kg Bulk Thermoplastic Dental Resin FDA UDI
- Model / Reference
- DC-DISC-P1-9825 EUDAMEDDC-DISC-G2-9820 EUDAMEDDC-DISC-A1-9820 EUDAMEDDC-DISC-A1-9825 EUDAMEDDC-DISC-P1-9815 EUDAMEDDC-DISC-G2-9825 EUDAMEDDC-DISC-A2-9820 EUDAMEDDC-DISC-A5-9825 EUDAMEDDC-DISC-A5-9820 EUDAMEDDC-DISC-A2-9825 EUDAMEDDC-DISC-B1-9825 EUDAMEDDC-B10-12.5kg EUDAMEDFDA UDI
- Description
- Shade B1-12.5kg Bulk Thermoplastic Dental Resin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326104600 EUDAMED00842326104563 EUDAMED00842326104440 EUDAMED00842326104457 EUDAMED00842326104587 EUDAMED00842326104570 EUDAMED00842326104471 EUDAMED00842326104518 EUDAMED00842326104501 EUDAMED00842326104488 EUDAMED00842326104549 EUDAMED00842326103436 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423261ThermoplasticDR5S EUDAMED
- FDA Product Code
- EBI FDA UDIEHP 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 UDI872.3285 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
Dimensions & Sizes
- Size
- Weight — 12.5 Kilogram FDA UDI
DuraCetal 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 (13)
- EUDAMED 0bff68da-b659-49a3-852d-49f9c4c7e799 61 fields · synced Aug 3, 2026
- EUDAMED f90430e6-2285-4638-9ffd-9adc1becf239 61 fields · synced May 16, 2026
- EUDAMED d85a213e-8825-4821-b5c3-4ec099c24f09 61 fields · synced May 16, 2026
- EUDAMED d115535a-72d4-427b-beb5-a939546a6a13 61 fields · synced May 16, 2026
- EUDAMED 94ace72d-6b61-4935-b47f-fb942f296785 61 fields · synced May 17, 2026
- EUDAMED f3ad0edf-e513-4b6e-aa33-1866e099329d 61 fields · synced May 17, 2026
- EUDAMED 63818268-7e1a-4ed7-b1d9-d0c6dfd57b9b 61 fields · synced May 17, 2026
- EUDAMED fea56a10-769e-4d16-9ed8-38e1dc063317 61 fields · synced May 17, 2026
- EUDAMED 381efd8f-074a-444b-918f-45eb90e7f6b6 61 fields · synced May 17, 2026
- EUDAMED 0adda422-21df-48df-8340-085e30069c19 61 fields · synced May 18, 2026
- EUDAMED a9d6ace1-0d31-4dc3-9e71-4ce5473b9efc 61 fields · synced May 18, 2026
- EUDAMED b0204b59-7297-4d86-b3be-6db5db33336c 61 fields · synced May 19, 2026
- FDA UDI b617b25f-6d60-48ce-8ec0-06f8611a86a9 35 fields · synced May 29, 2026