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Ceramill Zolid HT+ white 98x30
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 766028510(k) K171876
Identity
- Trade Name
- Ceramill Zolid HT+ white 98x30 EUDAMED
- Device Name
- zirconia class 5 EUDAMED
- Model / Reference
- 766028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E4947660281 EUDAMED
- Basic UDI-DI
- ++E494ZIRKON5F5 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Ceramill Zolid HT+ white 98x30 by Amann Girrbach AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K171876 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E494ZIRKON5F5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (3)
- EUDAMED 7f36b186-02d6-4cec-bfb3-8094d30abc55 85 fields · synced Oct 6, 2026
- EUDAMED 3e3a2bcc-b56e-4898-9d00-7b8c7fb67183 61 fields · synced Jul 15, 2026
- FDA 510(k) K171876 1 fields · synced May 18, 2026