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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K253343
Device Name Celebrace Software
Applicant
Celebrace
5708 Colleyville Blvd., Suite A
Colleyville,  TX  76034
Applicant Contact Sarah Moss
Correspondent
Celebrace
5708 Colleyville Blvd., Suite A
Colleyville,  TX  76034
Correspondent Contact Sarah Moss
Regulation Number872.5470
Classification Product Code
PNN  
Date Received09/30/2025
Decision Date 12/29/2025
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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