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Additive Manufacturing Zirconia Customized Restoration
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref T002Ref T003Ref T001Ref T004
Identity
- Trade Name
- Additive Manufacturing Zirconia Customized Restoration EUDAMED
- Device Name
- Additive Manufacturing Zirconia Customized Restoration EUDAMED
- Model / Reference
- T002 EUDAMEDT003 EUDAMEDT001 EUDAMEDT004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975409640024 EUDAMED06975409640031 EUDAMED06975409640017 EUDAMED06975409640048 EUDAMED
- Basic UDI-DI
- 697540964001LY EUDAMED
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS 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
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
Additive Manufacturing Zirconia Customized Restoration by Hangzhou Thales Medtech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240586 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697540964001LY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Thales Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000040285
- Authorised Representative
- NEO HEALTHIES LIMITED IE-AR-000000905
Sources (5)
- EUDAMED 9072a02b-c9ad-4065-bb79-053fe0be7f8a 61 fields · synced Aug 2, 2026
- EUDAMED 9f3add80-5f93-44a2-8f0c-ed83007697f1 61 fields · synced May 17, 2026
- EUDAMED cad95803-60f6-46bb-85dc-6159570ef50e 61 fields · synced May 18, 2026
- EUDAMED c38554e9-7748-4406-bee0-8ff81a458e16 61 fields · synced May 19, 2026
- FDA 510(k) K240586 1 fields · synced May 18, 2026