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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 K162890
Device Name BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
Applicant
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact JENNIFER M. JACKSON
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact JENNIFER M. JACKSON
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received10/17/2016
Decision Date 03/08/2017
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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