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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 K122855
Device Name TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
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 Number872.3640
Classification Product Code
DZE  
Date Received09/18/2012
Decision Date 12/12/2012
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
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