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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
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