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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K192202
Device Name Clear21
Applicant
World Class Technology Corporation
1300 NE Alpha Dr.
McMinnville,  OR  97128
Applicant Contact Alan Kozlowski
Correspondent
Allegiance Regulatory Consulting LLC
16642 SW Lansford Ct.
Beaverton,  OR  97007
Correspondent Contact Alyssa Thomas
Regulation Number872.5470
Classification Product Code
NJM  
Date Received08/14/2019
Decision Date 11/12/2019
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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