FDA 510(k)

BTI Interna Dental Implant System UnicCa - Prosthetic Components

Numéro K : K213106 · 2022-10-20

DemandeurB.T.I. Biotechnology Institute, Sl.

Date de décision2022-10-20

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K213106.

When did BTI Interna Dental Implant System UnicCa - Prosthetic Components receive FDA 510(k) clearance?

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

Who is the listed applicant for BTI Interna Dental Implant System UnicCa - Prosthetic Components?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Source officielle

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