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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 K063116
Device Name DEMETRON A.2
Applicant
Sybron Dental Specialties
100 Bayview Circle
Suite 6000
Newport Beach,  CA  92660 -8915
Applicant Contact COLLEEN BOSWELL
Correspondent
Sybron Dental Specialties
100 Bayview Circle
Suite 6000
Newport Beach,  CA  92660 -8915
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/12/2006
Decision Date 12/05/2006
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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