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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 K023748
Device Name FLASH-LITE II LED DENTAL CURING LIGHT
Applicant
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232 -2522
Applicant Contact GARY L HOLLAR
Correspondent
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232 -2522
Correspondent Contact GARY L HOLLAR
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/08/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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