Identity
- Trade Name
- Ceramill® ZI FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- ZI 77L (20mm) FDA UDI
Identifiers
- Catalog Number
- 760181 FDA UDI
- Primary DI / UDI-DI
- E4947601811 FDA UDI
- 510(k) Number
- K063511 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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® ZI by Amann Girrbach AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K063511 also covers:
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
- Ceramill® Liquid — Amann Girrbach AG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
Sources (1)
- FDA UDI 52b5578a-57fe-4df0-8a20-fa4adf7890b0 36 fields · synced Jun 1, 2026