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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 K121131
Device Name BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
Applicant
STRAUMANN USA
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
STRAUMANN USA
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/13/2012
Decision Date 06/06/2012
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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