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FDA 510(k)

3M Clear Tray Aligner

K-Number: K163689 · 2017-01-27

Applicant3M Unitek Corporation
Decision Date2017-01-27
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M Clear Tray Aligner is a medical device manufactured by 3M Unitek Corporation. It received FDA 510(k) clearance on 2017-01-27 under approval number K163689. 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 Clear Tray Aligner?

3M Clear Tray Aligner is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by 3M Unitek Corporation. The 510(k) number is K163689.

When was 3M Clear Tray Aligner approved by the FDA?

3M Clear Tray Aligner received FDA 510(k) clearance on 2017-01-27, under approval number K163689.

What company makes 3M Clear Tray Aligner?

3M Clear Tray Aligner is manufactured by 3M Unitek Corporation.

What is the FDA product code for 3M Clear Tray Aligner?

The FDA product code for 3M Clear Tray Aligner is NXC.

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems 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 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

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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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