FDA 510(k)

Dental Implant Unit

Número K: K242646 · 2025-04-11

RequerenteGuilin Aesthedent Medical Instruments Co., Ltd.

Data da decisão2025-04-11

Código do produtoEBW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Implant Unit is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Aesthedent Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242646. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Implant Unit?

Dental Implant Unit is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Guilin Aesthedent Medical Instruments Co., Ltd.. The 510(k) number is K242646.

When did Dental Implant Unit receive FDA 510(k) clearance?

Dental Implant Unit received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242646.

Who is the listed applicant for Dental Implant Unit?

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

What is the FDA product code for Dental Implant Unit?

The FDA product code for Dental Implant Unit is EBW.

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Fonte oficial

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