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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, orthodontic
510(k) Number K060062
Device Name STRAUMANN ORTHOSYSTEM
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 Number872.3640
Classification Product Code
OAT  
Date Received01/09/2006
Decision Date 02/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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