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FDA 510(k)

Clear Aligner

K-Number: K223517 · 2023-06-13

ApplicantWuxi EA Medical Instruments Technologies Limited.
Decision Date2023-06-13
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi EA Medical Instruments Technologies Limited.. It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K223517. 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 2023-06-13. The listed applicant is Wuxi EA Medical Instruments Technologies Limited.. The 510(k) number is K223517.

When did Clear Aligner receive FDA 510(k) clearance?

Clear Aligner received FDA 510(k) clearance on 2023-06-13, under 510(k) number K223517.

Who is the listed applicant for Clear Aligner?

The FDA 510(k) record lists Wuxi EA Medical Instruments Technologies Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Aligner?

The FDA product code for Clear Aligner is NXC.

Related Clinical Trials

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.

NCT06814262Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral IncisorsCOMPLETEDNCT07261735Clinical Evaluation of Customized Attachment Composites in Clear Aligner TherapyRECRUITINGNCT07290790A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.RECRUITINGNCT07420777Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open BiteRECRUITINGNCT07533058Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study.COMPLETEDNCT07533682Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical TrialNOT_YET_RECRUITING

Other records listing Wuxi EA Medical Instruments Technologies Limited. 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.

K203688Clear Aligner

Related Devices (Code: NXC)

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.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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