FDA 510(k)

Legacy SMARTBase Abutments

Número K: K191458 · 2019-10-10

RequerenteImplant Direct Sybron Manufacturing, LLC

Data da decisão2019-10-10

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Legacy SMARTBase Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K191458. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Legacy SMARTBase Abutments?

Legacy SMARTBase Abutments is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K191458.

When did Legacy SMARTBase Abutments receive FDA 510(k) clearance?

Legacy SMARTBase Abutments received FDA 510(k) clearance on 2019-10-10, under 510(k) number K191458.

Who is the listed applicant for Legacy SMARTBase Abutments?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legacy SMARTBase Abutments?

The FDA product code for Legacy SMARTBase Abutments is NHA.

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Fonte oficial

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