FDA 510(k)

BracePaste Fluoride Sealant

Número K: K242537 · 2024-08-27

Data da decisão2024-08-27

Código do produtoDYH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BracePaste Fluoride Sealant is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics Corp.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K242537. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BracePaste Fluoride Sealant?

BracePaste Fluoride Sealant is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is American Orthodontics Corp.. The 510(k) number is K242537.

When did BracePaste Fluoride Sealant receive FDA 510(k) clearance?

BracePaste Fluoride Sealant received FDA 510(k) clearance on 2024-08-27, under 510(k) number K242537.

Who is the listed applicant for BracePaste Fluoride Sealant?

The FDA 510(k) record lists American Orthodontics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BracePaste Fluoride Sealant?

The FDA product code for BracePaste Fluoride Sealant is DYH.

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Dispositivos Relacionados (Código: DYH)

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Fonte oficial

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