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Biodenta Dental Implant System - Multi-Use Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123491

by Biodenta Swiss AG

Identifiers

510(k) Number
K123491 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Biodenta Dental Implant System - Multi-Use Abutment is a prosthetic component system designed for use with endosseous dental implants. It functions as an interface between the dental implant and the final prosthesis.

This device is supplied as a multi-use abutment component within the Biodenta Dental Implant System. It is intended for use in dental restorative procedures and has received FDA 510(k) clearance under product code NHA, with the submission deemed substantially equivalent to a predicate device.

Frequently asked questions

What is the Biodenta Dental Implant System - Multi-Use Abutment used for?

It functions as a prosthetic component that serves as an interface between the dental implant and the final prosthesis in dental restorative procedures, enabling the attachment of crowns, bridges, or dentures to endosseous implants.

How is the Biodenta Multi-Use Abutment supplied and intended for use?

It is supplied as a multi-use abutment component within the Biodenta Dental Implant System, meaning it is designed to be cleaned, sterilized, and reused across multiple patient procedures following validated reprocessing protocols.

What regulatory pathway was used for the Biodenta Multi-Use Abutment, and what does its clearance status indicate?

The device received FDA 510(k) clearance under submission K123491, with a decision of 'Substantially Equivalent' to a predicate device, meaning it was determined to have the same intended use and similar technological characteristics as a legally marketed device.

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: Biodenta - Your Total Solution Provider, Biodenta Dental Implant System - Multi-use Abutment, PDF Product Catalog - Biodenta

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biodenta Swiss AG

Sources (1)

  • FDA 510(k) K123491 24 fields · synced Oct 6, 2026