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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K161684
Device Name Quantum LB
Applicant
Reliance Orthodontic Products, Inc.
1540 W. Thorndale Ave.
Itasca,  IL  60143
Applicant Contact Paula Wendland
Correspondent
Reliance Orthodontic Products, Inc.
1540 W. Thorndale Ave.
Itasca,  IL  60143
Correspondent Contact Paula Wendland
Regulation Number872.3750
Classification Product Code
DYH  
Date Received06/17/2016
Decision Date 10/06/2016
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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