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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name agent, tooth bonding, resin
510(k) Number K071688
Device Name RELIANCE S.E.P.
Applicant
RELIANCE ORTHODONTIC PRODUCTS, INC.
1540 WEST THORNDALE AVE.
ITASCA,  IL  60143
Applicant Contact PAUL GANGE
Correspondent
RELIANCE ORTHODONTIC PRODUCTS, INC.
1540 WEST THORNDALE AVE.
ITASCA,  IL  60143
Correspondent Contact PAUL GANGE
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/20/2007
Decision Date 09/07/2007
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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