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FDA 510(k)

Clear Aligner

K-Number: K203688 · 2021-10-08

ApplicantWuxi EA Medical Instruments Technologies Limited.
Decision Date2021-10-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clear Aligner is a medical device manufactured by Wuxi EA Medical Instruments Technologies Limited.. It received FDA 510(k) clearance on 2021-10-08 under approval number K203688. 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 Clear Aligner?

Clear Aligner is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Wuxi EA Medical Instruments Technologies Limited.. The 510(k) number is K203688.

When was Clear Aligner approved by the FDA?

Clear Aligner received FDA 510(k) clearance on 2021-10-08, under approval number K203688.

What company makes Clear Aligner?

Clear Aligner is manufactured by Wuxi EA Medical Instruments Technologies Limited..

What is the FDA product code for Clear Aligner?

The FDA product code for Clear 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

Other Devices by Wuxi EA Medical Instruments Technologies Limited.

K223517Clear Aligner

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

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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