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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 K002925
Device Name COOLBLU CURING LIGHT
Applicant
Dental Systems.Com, Inc.
1187 Tadsworth Trl.
Heathrow,  FL  32746
Applicant Contact SHINOBU DOI
Correspondent
Dental Systems.Com, Inc.
1187 Tadsworth Trl.
Heathrow,  FL  32746
Correspondent Contact SHINOBU DOI
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/19/2000
Decision Date 12/20/2000
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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