Identity
- Trade Name
- Medentika FDA UDI
- Generic Name
- Dental implant abutment analog, laboratory FDA UDI
- Device Name
- Laboratory implant CADCAM CS FDA UDI
- Model / Reference
- I 80-CS FDA UDI
- Description
- Laboratory implant CADCAM CS FDA UDI
Identifiers
- Catalog Number
- I 80-CS FDA UDI
- Primary DI / UDI-DI
- 04251574868534 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant abutment analog, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant abutment analog, laboratory
Medentika by Medentika GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA UDI 3fc24bb2-306e-4e3c-b831-f53f0ddc48de 34 fields · synced May 30, 2026