FDA 510(k)

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece

Número K: K262144 · 2026-09-23

Data da decisão2026-09-23

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is SETAGAYA SEIKI Co., Ltd.. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K262144. 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 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is SETAGAYA SEIKI Co., Ltd.. The 510(k) number is K262144.

When did DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece receive FDA 510(k) clearance?

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece received FDA 510(k) clearance on 2026-09-23, under 510(k) number K262144.

Who is the listed applicant for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?

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

What is the FDA product code for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?

The FDA product code for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece is EFB.

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