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FDA 510(k)

NEOLab Clear Aligners

K-Number: K192338 · 2020-03-12

ApplicantNew England Ortho Lab, Inc.
Decision Date2020-03-12
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEOLab Clear Aligners is a medical device manufactured by New England Ortho Lab, Inc.. It received FDA 510(k) clearance on 2020-03-12 under approval number K192338. 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 NEOLab Clear Aligners?

NEOLab Clear Aligners is a medical device that received FDA 510(k) clearance on 2020-03-12. It is manufactured by New England Ortho Lab, Inc.. The 510(k) number is K192338.

When was NEOLab Clear Aligners approved by the FDA?

NEOLab Clear Aligners received FDA 510(k) clearance on 2020-03-12, under approval number K192338.

What company makes NEOLab Clear Aligners?

NEOLab Clear Aligners is manufactured by New England Ortho Lab, Inc..

What is the FDA product code for NEOLab Clear Aligners?

The FDA product code for NEOLab Clear Aligners is NXC.

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05737290 Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding COMPLETED NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT07420777 Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite RECRUITING

Other Devices by New England Ortho Lab, Inc.

K203339NEOLab Clear Aligners

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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