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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name aligner, sequential
510(k) Number K221475
Device Name MyClearALIGN Dental Aligner System
Key Dental Technologies, LLC
920 MLK Blvd Suite 920-B
Chapel Hill,  NC  27517
Applicant Contact Larry Moray
Schiff & Company, Inc.
583 Mountain Avenue
North Caldwell,  NJ  07006
Correspondent Contact Thomas Padula
Regulation Number872.5470
Classification Product Code
Date Received05/20/2022
Decision Date 08/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No