Identity
- Trade Name
- Zolid gen-x BL3 98x16 EUDAMEDZolid Gen-X BL3 98x16 F EUDAMEDZolid FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- zirconia class 5 EUDAMED
- Model / Reference
- 766810 EUDAMED767530 EUDAMEDZolid gen-x BL3 98x16 FDA UDIZolid Gen-X BL3 98x16 F FDA UDI
Identifiers
- Catalog Number
- 766810 FDA UDI767530 FDA UDI
- Primary DI / UDI-DI
- E4947668101 EUDAMEDFDA UDIE4947675301 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
Zolid gen-x BL3 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (5)
- EUDAMED ba051350-ad39-4764-bb9d-92c01b9735ec 61 fields · synced Jul 9, 2026
- EUDAMED 7dd5a821-a48b-418b-a743-93a5f3652ce0 61 fields · synced May 18, 2026
- FDA UDI 287961dc-28ef-4246-97eb-9a4647895375 35 fields · synced May 29, 2026
- FDA UDI dd762636-8713-48db-a8a1-29552ee5f6c3 35 fields · synced May 30, 2026
- EUDAMED 60eebc11-b271-4ba9-beb6-3cae4d94a096 61 fields · synced Jul 9, 2026