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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 K162609
Device Name ClearPath Aligner
Applicant
Clearpath Orthodontics, Ltd.
6-N, Main Blvd.
Johar Town,  PK
Applicant Contact Waqas Wahab
Correspondent
Qserve Group, Us, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/19/2016
Decision Date 07/06/2017
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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