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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K962376
Device Name KREATIV KURING LIGHT SYSTEM
Applicant
Kreativ, Inc.
1517 Industrial Way, SW
Albany,  OR  97321
Applicant Contact CHARLES W WHUTCHINS
Correspondent
Kreativ, Inc.
1517 Industrial Way, SW
Albany,  OR  97321
Correspondent Contact CHARLES W WHUTCHINS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/20/1996
Decision Date 03/21/1997
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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