Identity
- Trade Name
- Z5c FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Two-piece root-form dental implant made of Zirconia Familiy Z5c Size Z5m-40-12 FDA UDI
- Model / Reference
- Z5c-40-12 FDA UDI
- Description
- Two-piece root-form dental implant made of Zirconia Familiy Z5c Size Z5m-40-12 FDA UDI
Identifiers
- Catalog Number
- Z5c-40-12 FDA UDI
- Primary DI / UDI-DI
- 07640166760429 FDA UDI
- 510(k) Number
- K132881 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDILength — 12 Millimeter FDA UDI
Z5c by Z-Systems AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K132881 also covers:
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
- Z-Systems AG
Sources (1)
- FDA UDI 8bdbcd65-bdd5-49cb-8cef-2baa8ca5301d 38 fields · synced Jun 8, 2026