FDA 510(k)

TRAUS Air Dental Handpiece

Número K: K221741 · 2023-02-22

Data da decisão2023-02-22

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRAUS Air Dental Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221741. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TRAUS Air Dental Handpiece?

TRAUS Air Dental Handpiece is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K221741.

When did TRAUS Air Dental Handpiece receive FDA 510(k) clearance?

TRAUS Air Dental Handpiece received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221741.

Who is the listed applicant for TRAUS Air Dental Handpiece?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAUS Air Dental Handpiece?

The FDA product code for TRAUS Air Dental Handpiece is EFB.

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Fonte oficial

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