FDA 510(k)

Sistema de Software Ortodôntico ArchForm

Número K: K213916 · 2021-12-16

Data da decisão2021-12-16

Código do produtoPNN

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ArchForm Orthodontic Software System is the device name listed in this FDA 510(k) record. The listed applicant is Archform, Inc.. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K213916. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ArchForm Orthodontic Software System?

ArchForm Orthodontic Software System is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Archform, Inc.. The 510(k) number is K213916.

When did ArchForm Orthodontic Software System receive FDA 510(k) clearance?

ArchForm Orthodontic Software System received FDA 510(k) clearance on 2021-12-16, under 510(k) number K213916.

Who is the listed applicant for ArchForm Orthodontic Software System?

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

What is the FDA product code for ArchForm Orthodontic Software System?

The FDA product code for ArchForm Orthodontic Software System is PNN.

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