FDA 510(k)

Composite Orthodontic Brackets and Buttons

Número K: K251196 · 2025-04-21

Data da decisão2025-04-21

Código do produtoDYW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Composite Orthodontic Brackets and Buttons is the device name listed in this FDA 510(k) record. The listed applicant is Ec Certification Service GmbH. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K251196. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Composite Orthodontic Brackets and Buttons?

Composite Orthodontic Brackets and Buttons is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Ec Certification Service GmbH. The 510(k) number is K251196.

When did Composite Orthodontic Brackets and Buttons receive FDA 510(k) clearance?

Composite Orthodontic Brackets and Buttons received FDA 510(k) clearance on 2025-04-21, under 510(k) number K251196.

Who is the listed applicant for Composite Orthodontic Brackets and Buttons?

The FDA 510(k) record lists Ec Certification Service GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Composite Orthodontic Brackets and Buttons?

The FDA product code for Composite Orthodontic Brackets and Buttons is DYW.

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Fonte oficial

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