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FDA 510(k)

MyClearALIGN Dental Aligner System

K-Number: K221475 · 2022-08-31

ApplicantKey Dental Technologies, LLC
Decision Date2022-08-31
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MyClearALIGN Dental Aligner System is a medical device manufactured by Key Dental Technologies, LLC. It received FDA 510(k) clearance on 2022-08-31 under approval number K221475. 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 MyClearALIGN Dental Aligner System?

MyClearALIGN Dental Aligner System is a medical device that received FDA 510(k) clearance on 2022-08-31. It is manufactured by Key Dental Technologies, LLC. The 510(k) number is K221475.

When was MyClearALIGN Dental Aligner System approved by the FDA?

MyClearALIGN Dental Aligner System received FDA 510(k) clearance on 2022-08-31, under approval number K221475.

What company makes MyClearALIGN Dental Aligner System?

MyClearALIGN Dental Aligner System is manufactured by Key Dental Technologies, LLC.

What is the FDA product code for MyClearALIGN Dental Aligner System?

The FDA product code for MyClearALIGN Dental Aligner System is NXC.

Related Clinical Trials

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07103941 IOA Preventing Occlusal Changes With MAD Use RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

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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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