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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K232011
Device Name Cleo
Applicant
American Orthodontics
3524 Washington Ave.
Sheboygan,  WI  53081
Applicant Contact Laura Richmond
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.5470
Classification Product Code
NJM  
Date Received07/06/2023
Decision Date 07/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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