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Ceramill Zolid HT+ PS D3 98x16
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 766258Ref 767734
Identity
- Trade Name
- Ceramill Zolid HT+ PS D3 98x16 EUDAMEDCeramill Zolid HT+ PS D3 98x16 F EUDAMEDCeramill® Zolid FDA UDICeramill FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- zirconia class 5 EUDAMED
- Model / Reference
- 766258 EUDAMED767734 EUDAMEDZolid HT+ PS D3 98x16 FDA UDICeramill Zolid HT+ PS D3 98x16 F FDA UDI
Identifiers
- Catalog Number
- 766258 FDA UDI767734 FDA UDI
- Primary DI / UDI-DI
- E4947662581 EUDAMEDFDA UDIE4947677341 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E494ZIRKON5F5 EUDAMED
- 510(k) Number
- K171876 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ceramill Zolid HT+ PS D3 98x16 by Amann Girrbach AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E494ZIRKON5F5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (5)
- EUDAMED d352bcc0-8d6a-444e-ad4d-ff7493cfad86 61 fields · synced Jul 11, 2026
- EUDAMED 0d03fed7-b4e9-46db-ae29-9484ee4886d8 61 fields · synced May 19, 2026
- FDA UDI 48b078e2-be75-444d-bc55-4cb92a68242f 35 fields · synced May 30, 2026
- FDA UDI a71e247c-a3c6-4537-aee4-2664e628fc85 35 fields · synced May 30, 2026
- EUDAMED bd99990e-7182-4ed9-a3fc-c154083808a8 61 fields · synced Jul 11, 2026