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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K060698
Device Name CEMENT-IT ALL PURPOSE, MODEL N97
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 Number872.3275
Classification Product Code
EMA  
Date Received03/16/2006
Decision Date 05/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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