dima Print Denture Base 2, Reddish Pink
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- dima Print Denture Base 2, Reddish Pink EUDAMEDdima Print Denture Base 2 EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Long-term Denture Base Resins EUDAMEDdima Print Denture Base 2 1kg - Reddish-Pink FDA UDI
- Model / Reference
- 12090202 EUDAMED66100850 EUDAMED1kg - Reddish-Pink FDA UDI
- Description
- dima Print Denture Base 2 1kg - Reddish-Pink FDA UDI
Identifiers
- Catalog Number
- 66100850 FDA UDI
- Primary DI / UDI-DI
- EPRC66100850 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EPRC66100850 EUDAMED++EPRC12090202CT EUDAMED
- 510(k) Number
- K210298 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMEDQ010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Temporary dental crown/bridge
dima Print Denture Base 2, Reddish Pink by pro3dure medical GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-EPRC66100850 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-EPRC66100850 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- pro3dure medical GmbH
- EUDAMED SRN
- DE-MF-000000024
Sources (3)
- EUDAMED 41c7986f-28d3-471c-82d9-43461385c0d3 61 fields · synced Jul 22, 2026
- FDA UDI 00bc42bd-78bb-4d6c-a5b8-2dc07d2e18fb 37 fields · synced May 30, 2026
- EUDAMED 968319ec-15e7-4147-b89b-d670f923106e 61 fields · synced Jul 9, 2026