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FDA 510(k)

Clear Image Aligners

K-Number: K183643 · 2019-01-03

ApplicantSpecialty Appliance Works, Inc.
Decision Date2019-01-03
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clear Image Aligners is a medical device manufactured by Specialty Appliance Works, Inc.. It received FDA 510(k) clearance on 2019-01-03 under approval number K183643. 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 Image Aligners?

Clear Image Aligners is a medical device that received FDA 510(k) clearance on 2019-01-03. It is manufactured by Specialty Appliance Works, Inc.. The 510(k) number is K183643.

When was Clear Image Aligners approved by the FDA?

Clear Image Aligners received FDA 510(k) clearance on 2019-01-03, under approval number K183643.

What company makes Clear Image Aligners?

Clear Image Aligners is manufactured by Specialty Appliance Works, Inc..

What is the FDA product code for Clear Image Aligners?

The FDA product code for Clear Image 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

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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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