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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 K885010
Device Name TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
Applicant
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Applicant Contact DEMKE, DDS
Correspondent
Coe Laboratories, Inc.
3737 W. 127th St.
Alsip,  IL  60658
Correspondent Contact DEMKE, DDS
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/02/1988
Decision Date 02/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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