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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
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