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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K201940
Device Name Braces on Demand Bracket
Applicant
Braces on Demand, Inc.
422 S. Broadway, Suite 223
Hicksville,  NY  11801
Applicant Contact Colin Corey
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
DYW  
Subsequent Product Code
PNN  
Date Received07/13/2020
Decision Date 12/03/2020
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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