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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 K150938
Device Name Straumann® Dental Implant System ¿ Roxolid® SLA Implants
Applicant
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/07/2015
Decision Date 07/24/2015
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
Recalls CDRH Recalls
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