Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DenMat Orthodontic Aligners

K-Number: K192470 · 2019-12-20

ApplicantDenmat Holdings, LLC
Decision Date2019-12-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DenMat Orthodontic Aligners is a medical device manufactured by Denmat Holdings, LLC. It received FDA 510(k) clearance on 2019-12-20 under approval number K192470. 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 DenMat Orthodontic Aligners?

DenMat Orthodontic Aligners is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Denmat Holdings, LLC. The 510(k) number is K192470.

When was DenMat Orthodontic Aligners approved by the FDA?

DenMat Orthodontic Aligners received FDA 510(k) clearance on 2019-12-20, under approval number K192470.

What company makes DenMat Orthodontic Aligners?

DenMat Orthodontic Aligners is manufactured by Denmat Holdings, LLC.

What is the FDA product code for DenMat Orthodontic Aligners?

The FDA product code for DenMat Orthodontic Aligners is NXC.

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT05905224 Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol COMPLETED NCT06731465 Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment ENROLLING_BY_INVITATION NCT07566533 Comparison of Single-Layer and Triple-Layer TPU MaxFlex Aligners After Intraoral Use COMPLETED

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.

↑