FDA 510(k)

Dental Air Polishing Handpiece

Número K: K221548 · 2022-09-28

RequerenteGuilin Woodpecker Medical Instrument Co., Ltd.

Data da decisão2022-09-28

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Air Polishing Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K221548. 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 Dental Air Polishing Handpiece?

Dental Air Polishing Handpiece is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K221548.

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

Dental Air Polishing Handpiece received FDA 510(k) clearance on 2022-09-28, under 510(k) number K221548.

Who is the listed applicant for Dental Air Polishing Handpiece?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Outros registros que listam Guilin Woodpecker Medical Instrument Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: EFB)

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Fonte oficial

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