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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 Rd.
Andover,  MA  01810
Applicant Contact JENNIFER M JACKSON, MS
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
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
Predetermined Change
Control Plan Authorized		 No
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