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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K252760
Device Name Carriere® Motion Pro® Clear Bite Corrector
Applicant
Ortho Organizers, Inc.
1822 Aston Ave.
Carlsbad,  CA  92008
Applicant Contact Thomas Arnold
Correspondent
Ortho Organizers, Inc.
1822 Aston Ave.
Carlsbad,  CA  92008
Correspondent Contact Thomas Arnold
Regulation Number872.5470
Classification Product Code
DYW  
Subsequent Product Code
EJF  
Date Received08/29/2025
Decision Date 11/27/2025
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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