Biodenta Dental Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093630 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biodenta Dental Implant System is a dental implant system, classified as an Endosseous Dental Implant. It is designed to provide a solution for dental implant procedures.
The system is supplied by Biodenta Swiss AG and has received FDA 510K authorization. The device is part of the product code DZE and has a specific K number, K093630. It is intended for use in dental procedures, with the company providing a systems-based approach to dentistry.
Frequently asked questions
What is the Biodenta Dental Implant System used for?
The Biodenta Dental Implant System is used for dental implant procedures, providing a solution for patients in need of dental implants.
What kind of authorization has the Biodenta Dental Implant System received?
The Biodenta Dental Implant System has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.
How is the Biodenta Dental Implant System classified?
The Biodenta Dental Implant System is classified as an Endosseous Dental Implant, which is part of the product code DZE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Total Solution Provider - Biodenta - Your Total Solution Provider, K123491 FDA 510(k) - BIODENTA DENTAL IMPLANT SYSTEM - MULTI-..., Biodenta Dental Implants | SpotImplant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093630 | Class II | Active |
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Manufacturer
- Manufacturer
- Biodenta Swiss AG
Sources (1)
- FDA 510(k) K093630 24 fields · synced Oct 6, 2026