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FDA 510(k)

PlaniMax Orthodontic Software

K-Number: K201036 · 2020-12-22

Decision Date2020-12-22
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PlaniMax Orthodontic Software is a medical device manufactured by Choice Biotech, Inc.. It received FDA 510(k) clearance on 2020-12-22 under approval number K201036. 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 PlaniMax Orthodontic Software?

PlaniMax Orthodontic Software is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Choice Biotech, Inc.. The 510(k) number is K201036.

When was PlaniMax Orthodontic Software approved by the FDA?

PlaniMax Orthodontic Software received FDA 510(k) clearance on 2020-12-22, under approval number K201036.

What company makes PlaniMax Orthodontic Software?

PlaniMax Orthodontic Software is manufactured by Choice Biotech, Inc..

What is the FDA product code for PlaniMax Orthodontic Software?

The FDA product code for PlaniMax Orthodontic Software is PNN.

Related Clinical Trials

Related Devices (Code: PNN)

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.