FDA 510(k)

Abutamento ATLANTIS para NobelActive 3.0

Número K: K151039 · 2016-01-14

Data da decisão2016-01-14

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ATLANTIS Abutment for NobelActive 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K151039. 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 ATLANTIS Abutment for NobelActive 3.0?

ATLANTIS Abutment for NobelActive 3.0 is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Dentsply International, Inc.. The 510(k) number is K151039.

When did ATLANTIS Abutment for NobelActive 3.0 receive FDA 510(k) clearance?

ATLANTIS Abutment for NobelActive 3.0 received FDA 510(k) clearance on 2016-01-14, under 510(k) number K151039.

Who is the listed applicant for ATLANTIS Abutment for NobelActive 3.0?

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

What is the FDA product code for ATLANTIS Abutment for NobelActive 3.0?

The FDA product code for ATLANTIS Abutment for NobelActive 3.0 is NHA.

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Fonte oficial

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