FDA 510(k)

ArchForm Orthodontic Software System

K-Number: K213916 · 2021-12-16

Decision Date2021-12-16

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Archform, Inc.. The 510(k) number is K213916.

When was ArchForm Orthodontic Software System approved by the FDA?

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

What company makes ArchForm Orthodontic Software System?

ArchForm Orthodontic Software System is manufactured by Archform, Inc..

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.