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dima Print Splint clear
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 66077916Model 12090201
Identity
- Trade Name
- dima Print Splint clear EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Long-term dental guide & splint resins EUDAMEDLight curing liquid for 3D-printing FDA UDI
- Model / Reference
- 12090201 EUDAMED66077916 EUDAMED1kg FDA UDI
- Description
- Light curing liquid for 3D-printing FDA UDI
Identifiers
- Primary DI / UDI-DI
- EPRC66077916 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EPRC66077916 EUDAMED
- 510(k) Number
- K211415 FDA UDI
- FDA Product Code
- MQC FDA UDIEBI FDA UDIKMY FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.5525 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
dima Print Splint clear by pro3dure medical GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-EPRC66077916 | 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 (2)
- EUDAMED e7ba009b-1533-43ce-be8b-96057f6a36ec 61 fields · synced Jul 26, 2026
- FDA UDI c4f09804-3102-4ffe-bedb-4e3fab4a4357 36 fields · synced May 30, 2026