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FDA 510(k)

3M Clarity Aligners

K-Number: K192119 · 2019-09-05

Applicant3M Company
Decision Date2019-09-05
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M Clarity Aligners is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2019-09-05 under approval number K192119. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M Clarity Aligners?

3M Clarity Aligners is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by 3M Company. The 510(k) number is K192119.

When was 3M Clarity Aligners approved by the FDA?

3M Clarity Aligners received FDA 510(k) clearance on 2019-09-05, under approval number K192119.

What company makes 3M Clarity Aligners?

3M Clarity Aligners is manufactured by 3M Company.

What is the FDA product code for 3M Clarity Aligners?

The FDA product code for 3M Clarity Aligners is NXC.

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Related Devices (Code: NXC)

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.