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FDA 510(k)

BRIUS Clear Aligners

K-Number: K202792 · 2021-01-22

ApplicantBrius Technologies, Inc.
Decision Date2021-01-22
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRIUS Clear Aligners is a medical device manufactured by Brius Technologies, Inc.. It received FDA 510(k) clearance on 2021-01-22 under approval 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. It is manufactured by Brius Technologies, Inc.. The 510(k) number is K202792.

When was BRIUS Clear Aligners approved by the FDA?

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

What company makes BRIUS Clear Aligners?

BRIUS Clear Aligners is manufactured by Brius Technologies, Inc..

What is the FDA product code for BRIUS Clear Aligners?

The FDA product code for BRIUS Clear Aligners is NXC.

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05737290 Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding COMPLETED NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT07420777 Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite RECRUITING

Other Devices by Brius Technologies, Inc.

K212828BRIUS Planner Software

Related Devices (Code: NXC)

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Official Source

View on FDA Database →

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

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