FDA 510(k)

AccelX Abutments

Número K: K203240 · 2021-04-27

RequerenteIntegrated Dental Systems, LLC

Data da decisão2021-04-27

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AccelX Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Dental Systems, LLC. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K203240. 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 AccelX Abutments?

AccelX Abutments is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Integrated Dental Systems, LLC. The 510(k) number is K203240.

When did AccelX Abutments receive FDA 510(k) clearance?

AccelX Abutments received FDA 510(k) clearance on 2021-04-27, under 510(k) number K203240.

Who is the listed applicant for AccelX Abutments?

The FDA 510(k) record lists Integrated Dental Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccelX Abutments?

The FDA product code for AccelX Abutments is NHA.

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Fonte oficial

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