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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 K061981
Device Name SURPASS
Applicant
Apex Dental Materials, Inc.
23329 Mallard Ct.
Deer Park,  IL  60010
Applicant Contact CHRIS KULTON
Correspondent
Apex Dental Materials, Inc.
23329 Mallard Ct.
Deer Park,  IL  60010
Correspondent Contact CHRIS KULTON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/13/2006
Decision Date 07/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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