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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K143209
Device Name SonicFill 2
Applicant
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact KERRI CASINO
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact KERRI CASINO
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBC  
Date Received11/10/2014
Decision Date 02/05/2015
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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