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FDA 510(k)

BTI Interna Dental Implant System UnicCa - Prosthetic Components

K-Number: K213106 · 2022-10-20

Decision Date2022-10-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Interna Dental Implant System UnicCa - Prosthetic Components is a medical device manufactured by B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2022-10-20 under approval number K213106. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTI Interna Dental Implant System UnicCa - Prosthetic Components?

BTI Interna Dental Implant System UnicCa - Prosthetic Components is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K213106.

When was BTI Interna Dental Implant System UnicCa - Prosthetic Components approved by the FDA?

BTI Interna Dental Implant System UnicCa - Prosthetic Components received FDA 510(k) clearance on 2022-10-20, under approval number K213106.

What company makes BTI Interna Dental Implant System UnicCa - Prosthetic Components?

BTI Interna Dental Implant System UnicCa - Prosthetic Components is manufactured by B.T.I. Biotechnology Institute, Sl..

What is the FDA product code for BTI Interna Dental Implant System UnicCa - Prosthetic Components?

The FDA product code for BTI Interna Dental Implant System UnicCa - Prosthetic Components is NHA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.