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Dental Zirconia Ceramics
EUDAMEDClass IIa (EU MDR)
Ref 06979063053848Model 3D-PRO-16
Identity
- Trade Name
- Dental Zirconia Ceramics EUDAMED
- Device Name
- Dental Zirconia Ceramics EUDAMED
- Model / Reference
- 3D-PRO-16 EUDAMED06979063053848 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979063053848 EUDAMED
- Basic UDI-DI
- B-06979063053848 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER 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
Yes
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
Category: Dental appliance fabrication material, ceramic
Dental Zirconia Ceramics by Audental Bio-Material Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06979063053848 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Audental Bio-Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000023257
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6c8c94bc-225c-45df-969a-1bedf7d24fa9 61 fields · synced Jun 18, 2026