FDA 510(k)

BioClean Implant Restorative System

Número K: K222984 · 2022-12-29

Data da decisão2022-12-29

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioClean Implant Restorative System is the device name listed in this FDA 510(k) record. The listed applicant is Bioclean Dental, LLC. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K222984. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioClean Implant Restorative System?

BioClean Implant Restorative System is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Bioclean Dental, LLC. The 510(k) number is K222984.

When did BioClean Implant Restorative System receive FDA 510(k) clearance?

BioClean Implant Restorative System received FDA 510(k) clearance on 2022-12-29, under 510(k) number K222984.

Who is the listed applicant for BioClean Implant Restorative System?

The FDA 510(k) record lists Bioclean Dental, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioClean Implant Restorative System?

The FDA product code for BioClean Implant Restorative System is NHA.

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Fonte oficial

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