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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K063812
Device Name STRAUMANN PREFGEL
Applicant
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact LISA M QUAGLIA
Correspondent
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact LISA M QUAGLIA
Classification Product Code
KJJ  
Date Received12/22/2006
Decision Date 01/12/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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