Identity
- Trade Name
- Z5c FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Abutment made of Zirconia Familiy Z5c Size Z5c-A15, 15° angulated FDA UDI
- Model / Reference
- Z5c-A15 FDA UDI
- Description
- Abutment made of Zirconia Familiy Z5c Size Z5c-A15, 15° angulated FDA UDI
Identifiers
- Catalog Number
- Z5c-A15 FDA UDI
- Primary DI / UDI-DI
- 07640166760467 FDA UDI
- 510(k) Number
- FDA Product Code
- DZE FDA 510(k)NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)872.3630 FDA UDI
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 0 degree FDA UDI
Z5c by Z-Systems AG — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132881 | Class II | Active |
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Manufacturer
- Manufacturer
- Z-Systems AG
Sources (2)
- FDA 510(k) K132881 24 fields · synced Jun 18, 2026
- FDA UDI f72f3401-7056-4a93-9106-ff37463232cd 37 fields · synced May 27, 2026