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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 K072807
Device Name I LIGHT
Applicant
Dent'N CO
11440 W. Bernardo Ct.
Suite 200
San Diego,  CA  92127
Applicant Contact ALAN DONALD
Correspondent
Dent'N CO
11440 W. Bernardo Ct.
Suite 200
San Diego,  CA  92127
Correspondent Contact ALAN DONALD
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/01/2007
Decision Date 11/21/2007
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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