FDA 510(k)

Invisalign System with Mandibular Advancement Feature

Número K: K181739 · 2018-10-26

Data da decisão2018-10-26

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Invisalign System with Mandibular Advancement Feature is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K181739. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Invisalign System with Mandibular Advancement Feature?

Invisalign System with Mandibular Advancement Feature is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Align Technology, Inc.. The 510(k) number is K181739.

When did Invisalign System with Mandibular Advancement Feature receive FDA 510(k) clearance?

Invisalign System with Mandibular Advancement Feature received FDA 510(k) clearance on 2018-10-26, under 510(k) number K181739.

Who is the listed applicant for Invisalign System with Mandibular Advancement Feature?

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

What is the FDA product code for Invisalign System with Mandibular Advancement Feature?

The FDA product code for Invisalign System with Mandibular Advancement Feature is NXC.

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Outros registros que listam Align Technology, Inc. como candidato(a)

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Dispositivos Relacionados (Código: NXC)

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Fonte oficial

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