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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
Applicant
Key Dental Technologies, LLC
920 Mlk Blvd. Suite 920-B
Chapel Hill,  NC  27517
Applicant Contact Larry Moray
Correspondent
Schiff & Company, Inc.
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact Thomas Padula
Regulation Number872.5470
Classification Product Code
NXC  
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
Predetermined Change
Control Plan Authorized		 No
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