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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 the device name listed in this FDA 510(k) record. The listed applicant is Key Dental Technologies, LLC. It received FDA 510(k) clearance on 2022-08-31 under 510(k) 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. The listed applicant is Key Dental Technologies, LLC. The 510(k) number is K221475.

When did MyClearALIGN Dental Aligner System receive FDA 510(k) clearance?

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

Who is the listed applicant for MyClearALIGN Dental Aligner System?

The FDA 510(k) record lists Key Dental Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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