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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K060469
Device Name OPTIBOND ALL-IN-ONE
Applicant
Sybron Dental Specialties, Inc.
100 Bayview Cir.
Suite 6000
Newport Beach,  CA  92660
Applicant Contact COLLEEN BOSWELL
Correspondent
Sybron Dental Specialties, Inc.
100 Bayview Cir.
Suite 6000
Newport Beach,  CA  92660
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/23/2006
Decision Date 03/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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