FDA 510(k)

Clear Aligner

K-Number: K192767 · 2020-01-08

Decision Date2020-01-08

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 Royal Dental Lab. It received FDA 510(k) clearance on 2020-01-08 under 510(k) number K192767. 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 2020-01-08. The listed applicant is Royal Dental Lab. The 510(k) number is K192767.

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

Clear Aligner received FDA 510(k) clearance on 2020-01-08, under 510(k) number K192767.

Who is the listed applicant for Clear Aligner?

The FDA 510(k) record lists Royal Dental Lab 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 IncisorsCOMPLETED NCT07261735Clinical Evaluation of Customized Attachment Composites in Clear Aligner TherapyRECRUITING NCT07290790A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.RECRUITING NCT07420777Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open BiteRECRUITING NCT07533058Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study.COMPLETED NCT07533682Comparison of Maxillary Dental Expansion Using Smartee Clear Aligner With and Without S11 Expander: A Randomized Clinical TrialNOT_YET_RECRUITING

Related Devices (Code: NXC)

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) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

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