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FDA 510(k)

Custom Clear Aligner System

K-Number: K173785 · 2018-03-13

ApplicantDerby Dental Laboratory
Decision Date2018-03-13
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Custom Clear Aligner System is a medical device manufactured by Derby Dental Laboratory. It received FDA 510(k) clearance on 2018-03-13 under approval number K173785. 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 Custom Clear Aligner System?

Custom Clear Aligner System is a medical device that received FDA 510(k) clearance on 2018-03-13. It is manufactured by Derby Dental Laboratory. The 510(k) number is K173785.

When was Custom Clear Aligner System approved by the FDA?

Custom Clear Aligner System received FDA 510(k) clearance on 2018-03-13, under approval number K173785.

What company makes Custom Clear Aligner System?

Custom Clear Aligner System is manufactured by Derby Dental Laboratory.

What is the FDA product code for Custom Clear Aligner System?

The FDA product code for Custom Clear Aligner System is NXC.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT04786821 Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis COMPLETED NCT07193407 INOPASE - Performance and Safety Study of a Personalised SNM System RECRUITING

Related PubMed Literature

PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019)

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

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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