FDA 510(k)

BRIUS Clear Aligners

K-Number: K202792 · 2021-01-22

Decision Date2021-01-22

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BRIUS Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Brius Technologies, Inc.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K202792. 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 BRIUS Clear Aligners?

BRIUS Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Brius Technologies, Inc.. The 510(k) number is K202792.

When did BRIUS Clear Aligners receive FDA 510(k) clearance?

BRIUS Clear Aligners received FDA 510(k) clearance on 2021-01-22, under 510(k) number K202792.

Who is the listed applicant for BRIUS Clear Aligners?

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

What is the FDA product code for BRIUS Clear Aligners?

The FDA product code for BRIUS Clear Aligners is NXC.

Other records listing Brius Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212828BRIUS Planner Software

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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.