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Ceramill Zolid HT+ PS B3 98x20 F
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 767710Ref 766211
Identity
- Trade Name
- Ceramill Zolid HT+ PS B3 98x20 F EUDAMEDCeramill Zolid HT+ PS B3 98x20 EUDAMEDCeramill FDA UDICeramill® Zolid FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- zirconia class 5 EUDAMED
- Model / Reference
- 767710 EUDAMED766211 EUDAMEDCeramill Zolid HT+ PS B3 98x20 F FDA UDIZolid HT+ PS B3 98x20 FDA UDI
Identifiers
- Catalog Number
- 767710 FDA UDI766211 FDA UDI
- Primary DI / UDI-DI
- E4947677101 EUDAMEDFDA UDIE4947662111 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
No
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 B3 98x20 F 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 61c096d7-97a1-4fd4-a950-660a79b0ac2f 61 fields · synced Oct 6, 2026
- EUDAMED a8fcb235-b618-475b-8e20-0a70038519a9 61 fields · synced May 18, 2026
- FDA UDI 28e574ee-4d18-4b71-ba27-c75b77beafef 35 fields · synced May 30, 2026
- FDA UDI 40bb2803-fd3c-46e7-b090-6588cd810572 35 fields · synced May 30, 2026
- EUDAMED c1b378ad-cbe1-4eb7-843f-d03b404786e8 61 fields · synced Jul 18, 2026