FDA 510(k)

Anatotemp Implant de Sinoanatômico de Cura de Dente

Número K: K171922 · 2017-09-28

RequerenteBuckeye Medical Technologies, LLC

Data da decisão2017-09-28

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anatotemp Anatomic Dental Implant Healing Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Buckeye Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K171922. 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 Anatotemp Anatomic Dental Implant Healing Abutment?

Anatotemp Anatomic Dental Implant Healing Abutment is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Buckeye Medical Technologies, LLC. The 510(k) number is K171922.

When did Anatotemp Anatomic Dental Implant Healing Abutment receive FDA 510(k) clearance?

Anatotemp Anatomic Dental Implant Healing Abutment received FDA 510(k) clearance on 2017-09-28, under 510(k) number K171922.

Who is the listed applicant for Anatotemp Anatomic Dental Implant Healing Abutment?

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

What is the FDA product code for Anatotemp Anatomic Dental Implant Healing Abutment?

The FDA product code for Anatotemp Anatomic Dental Implant Healing Abutment is NHA.

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Fonte oficial

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