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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K193385
Device Name TP Orthodontics Clear Aligner System
Applicant
Tp Orthodontics, Inc.
100 Center Plaza
La Porte,  IN  46350 -9672
Applicant Contact Stephanie Thyen
Correspondent
Tp Orthodontics, Inc.
100 Center Plaza
La Porte,  IN  46350 -9672
Correspondent Contact Stephanie Thyen
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/06/2019
Decision Date 11/12/2020
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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