FDA 510(k)

Dental Desensitizer

Número K: K222891 · 2023-05-25

RequerenteGuangzhou Beogene Biotech Co., Ltd.

Data da decisão2023-05-25

Código do produtoLBH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Beogene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222891. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Desensitizer?

Dental Desensitizer is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Guangzhou Beogene Biotech Co., Ltd.. The 510(k) number is K222891.

When did Dental Desensitizer receive FDA 510(k) clearance?

Dental Desensitizer received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222891.

Who is the listed applicant for Dental Desensitizer?

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

What is the FDA product code for Dental Desensitizer?

The FDA product code for Dental Desensitizer is LBH.

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