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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 K020091
Device Name OPTILUX 501
Applicant
Kerr Corporation (Danbury)
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
Kerr Corporation (Danbury)
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/10/2002
Decision Date 03/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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