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FDA 510(k)

Clear Aligners

K-Number: K210373 · 2021-08-27

ApplicantShenzhen Yinuo Dental Technology Co.Ltd
Decision Date2021-08-27
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yinuo Dental Technology Co.Ltd. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210373. 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 Aligners?

Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Shenzhen Yinuo Dental Technology Co.Ltd. The 510(k) number is K210373.

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

Clear Aligners received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210373.

Who is the listed applicant for Clear Aligners?

The FDA 510(k) record lists Shenzhen Yinuo Dental Technology Co.Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Aligners?

The FDA product code for Clear Aligners 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.

NCT04815564Clear Aligners for the Treatment of Dental Malocclusion in OIACTIVE_NOT_RECRUITINGNCT05573308Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence AlgorithmsRECRUITINGNCT05737290Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior CrowdingCOMPLETEDNCT06731465Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor TreatmentENROLLING_BY_INVITATIONNCT07261735Clinical 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.RECRUITING

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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