Clear-Aligners
K-Number: K191823 · 2019-12-20
ApplicantCdb Corporation
Decision Date2019-12-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Clear-Aligners is a medical device manufactured by Cdb Corporation. It received FDA 510(k) clearance on 2019-12-20 under approval number K191823. 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-Aligners?
Clear-Aligners is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Cdb Corporation. The 510(k) number is K191823.
When was Clear-Aligners approved by the FDA?
Clear-Aligners received FDA 510(k) clearance on 2019-12-20, under approval number K191823.
What company makes Clear-Aligners?
Clear-Aligners is manufactured by Cdb Corporation.
What is the FDA product code for Clear-Aligners?
The FDA product code for 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 Cdb Corporation
Related Devices (Code: NXC)
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.