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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K073628
Device Name SYNOCTA ABUTMENTS
Applicant
Straumann USA
6 0 Minuteman Rd.
Andover,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
Straumann USA
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/26/2007
Decision Date 01/22/2008
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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