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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, root-form
510(k) Number K130222
Device Name STRAUMANN DENTAL IMPLANT SYSTEM
Applicant
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact JENNIFER M JACKSON, MS
Correspondent
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact JENNIFER M JACKSON, MS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/29/2013
Decision Date 04/29/2013
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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