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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 K140512
Device Name UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE
Applicant
Juno Dentistry LP
848-1/2 Derby Ave.
Orange,  CT  06477
Applicant Contact ROGER MASTRONY
Correspondent
Juno Dentistry LP
848-1/2 Derby Ave.
Orange,  CT  06477
Correspondent Contact ROGER MASTRONY
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/28/2014
Decision Date 07/02/2014
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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