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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K061277
Device Name STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
Applicant
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/08/2006
Decision Date 04/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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