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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 K070549
Device Name STRAUMANN P.004 RC GOLD ABUTMENT
Applicant
INSTITUT STRAUMANN AG
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
INSTITUT STRAUMANN AG
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/26/2007
Decision Date 08/31/2007
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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