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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 Plaza
La Porte,  IN  46350 -9672
Applicant Contact Cristiane Muller
Correspondent
TP Orthodontics, Inc.
100 Center Plaza
La Porte,  IN  46350 -9672
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
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