Identity
- Trade Name
- freeprint temp A2 385 1.000 g EUDAMED
- Device Name
- Wiederherstellungsmaterial, dental, Krone und Brücke 3D EUDAMED
- Model / Reference
- 04063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET040631 EUDAMED
- Basic UDI-DI
- ++EDET0275S EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental appliance fabrication material, resin
freeprint temp A2 385 1.000 g by DETAX GmbH & Co. KG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200273 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++EDET0275S | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (2)
- EUDAMED e8e30298-6d7a-4d06-8ff5-2b71a7e2e3fb 61 fields · synced Jun 20, 2026
- FDA 510(k) K200273 1 fields · synced May 18, 2026