FDA 510(k)

Microimplante Absoanchor

Número K: K181142 · 2019-02-05

Data da decisão2019-02-05

Código do produtoOAT

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Absoanchor Microimplant is the device name listed in this FDA 510(k) record. The listed applicant is Dentos, Inc.. It received FDA 510(k) clearance on 2019-02-05 under 510(k) number K181142. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Absoanchor Microimplant?

Absoanchor Microimplant is a medical device that received FDA 510(k) clearance on 2019-02-05. The listed applicant is Dentos, Inc.. The 510(k) number is K181142.

When did Absoanchor Microimplant receive FDA 510(k) clearance?

Absoanchor Microimplant received FDA 510(k) clearance on 2019-02-05, under 510(k) number K181142.

Who is the listed applicant for Absoanchor Microimplant?

The FDA 510(k) record lists Dentos, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Absoanchor Microimplant?

The FDA product code for Absoanchor Microimplant is OAT.

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