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FDA 510(k)

Inman Digital Clear Aligners

K-Number: K210763 · 2021-09-29

ApplicantInman Orthodontic Laboratories, Inc.
Decision Date2021-09-29
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Inman Digital Clear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Inman Orthodontic Laboratories, Inc.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K210763. 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 Inman Digital Clear Aligners?

Inman Digital Clear Aligners is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Inman Orthodontic Laboratories, Inc.. The 510(k) number is K210763.

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

Inman Digital Clear Aligners received FDA 510(k) clearance on 2021-09-29, under 510(k) number K210763.

Who is the listed applicant for Inman Digital Clear Aligners?

The FDA 510(k) record lists Inman Orthodontic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inman Digital Clear Aligners?

The FDA product code for Inman Digital 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.

NCT05573308Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence AlgorithmsRECRUITINGNCT07261735Clinical Evaluation of Customized Attachment Composites in Clear Aligner TherapyRECRUITINGNCT07586163Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse DeficiencyACTIVE_NOT_RECRUITINGNCT07591025Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing PatientsCOMPLETEDNCT07637227Clinical Performance of Direct-Printed Versus Thermoformed AlignersRECRUITINGNCT07716007Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-Extraction Treatment of AdultsCOMPLETED

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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