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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 K093027
Device Name STRAUMANN RC TEMPORARY ABUTMENTS
Applicant
Straumann USA
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
Straumann USA
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/29/2009
Decision Date 02/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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