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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 K210320
Device Name ClearCorrect System
Applicant
Clearcorrect, LLC
21 Cypress Blvd., Suite 1010
Round Rock,  TX  78665
Applicant Contact Christopher Klaczyk
Correspondent
Clearcorrect, LLC
21 Cypress Blvd., Suite 1010
Round Rock,  TX  78665
Correspondent Contact Christopher Klaczyk
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/04/2021
Decision Date 08/06/2021
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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