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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 K073518
Device Name FLASHLITE REBEL*
Applicant
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Applicant Contact VIVIAN LAI
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN SIMON CHRISTENSON
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received12/14/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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