FDA 510(k)

Locator Overdenture Implant System

Número K: K203701 · 2021-04-15

RequerenteIvory Super Holdco Inc. / Zest Anchors, LLC

Data da decisão2021-04-15

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Locator Overdenture Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Super Holdco Inc. / Zest Anchors, LLC. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K203701. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Locator Overdenture Implant System?

Locator Overdenture Implant System is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Ivory Super Holdco Inc. / Zest Anchors, LLC. The 510(k) number is K203701.

When did Locator Overdenture Implant System receive FDA 510(k) clearance?

Locator Overdenture Implant System received FDA 510(k) clearance on 2021-04-15, under 510(k) number K203701.

Who is the listed applicant for Locator Overdenture Implant System?

The FDA 510(k) record lists Ivory Super Holdco Inc. / Zest Anchors, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Locator Overdenture Implant System?

The FDA product code for Locator Overdenture Implant System is DZE.

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