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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 K072545
Device Name ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
Applicant
PENTRON CLINICAL TECHNOLOGIES
68-70 NORTH PLAINS INDUSTRIAL
ROAD
WALLINGFORD,  CT  06492
Applicant Contact GREG MOREAU
Correspondent
PENTRON CLINICAL TECHNOLOGIES
68-70 NORTH PLAINS INDUSTRIAL
ROAD
WALLINGFORD,  CT  06492
Correspondent Contact GREG MOREAU
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/10/2007
Decision Date 10/26/2007
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
Recalls CDRH Recalls
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