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FDA 510(k)

Clear-Aligners

K-Number: K191823 · 2019-12-20

ApplicantCdb Corporation
Decision Date2019-12-20
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 Cdb Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191823. 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 2019-12-20. The listed applicant is Cdb Corporation. The 510(k) number is K191823.

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

Clear-Aligners received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191823.

Who is the listed applicant for Clear-Aligners?

The FDA 510(k) record lists Cdb Corporation 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

Other records listing Cdb Corporation 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.

K212173HDH Treatment Planning SystemK210613HIT Clear AlignerK160957CDB Self Ligating Bracket 8F

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

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

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