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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K042196
Device Name SAVEDENT BLUE
Applicant
Denfotex Light Systems, Ltd.
Unit 15, Belleknowes Ind.Est
Inverkeithing Fife, Scotland,  GB KY11 1H7
Applicant Contact JOHN COLLES
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact WILLIAM J SAMMONS
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received08/13/2004
Decision Date 11/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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