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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 K130237
Device Name PONTIC PAINT
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 Number872.5470
Classification Product Code
NXC  
Date Received01/31/2013
Decision Date 04/05/2013
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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