Identity
- Trade Name
- FRIADENT® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- MP Insert D4.5/GH9 FDA UDI
- Model / Reference
- 32462759 FDA UDI
- Description
- MP Insert D4.5/GH9 FDA UDI
Identifiers
- Catalog Number
- 46-2759 FDA UDI
- Primary DI / UDI-DI
- EFRI324627592 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
The FRIADENT is a prefabricated dental implant device designed to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration, featuring one or more structural components and materials. The device includes an abutment screw(s) that may be included, but the suprastructure does not represent the screw(s) in isolation.
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
- Dentsply Implants Manufacturing GmbH
Sources (1)
- FDA UDI 71423be1-e120-4c7f-a4c7-2ae70efd1e79 37 fields · synced Jul 30, 2026