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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K214054
Device Name TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
Applicant
Tp Orthodontics, Inc.
100 Center Plz.
La Porte,  IN  46350
Applicant Contact Cristiane Muller
Correspondent
Tp Orthodontics, Inc.
100 Center Plz.
La Porte,  IN  46350
Correspondent Contact Cristiane Muller
Regulation Number872.3750
Classification Product Code
DYH  
Subsequent Product Code
KLE  
Date Received12/27/2021
Decision Date 10/14/2022
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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