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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 K945698
Device Name COLTOLUX 3, COLTOLUX 4
Applicant
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact H J VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact H J VOGELSTEIN
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/17/1994
Decision Date 05/24/1995
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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