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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 K211427
Device Name CREOKORREKT Aligners
Applicant
Creodent Prosthetics, Ltd.
515 W. 45th St. 11fl
New York,  NY  10036
Applicant Contact Calvin Shim
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/07/2021
Decision Date 10/13/2022
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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