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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 K131049
Device Name ZRP
Applicant
APEX DENTAL MATERIALS, INC.
330 TELSER ROAD
LAKE ZURICH,  IL  60047
Applicant Contact CHRIS KULTON
Correspondent
APEX DENTAL MATERIALS, INC.
330 TELSER ROAD
LAKE ZURICH,  IL  60047
Correspondent Contact CHRIS KULTON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/15/2013
Decision Date 08/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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