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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 K200597
Device Name Straumann BLX Gold Abutments
Applicant
Straumann USA, LLC (On behalf of Institut Straumann AG)
60 Minuteman Road
Andover,  MA  01810
Applicant Contact Chanrasmey White
Correspondent
Straumann USA, LLC (On behalf of Institut Straumann AG)
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Chanrasmey White
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/09/2020
Decision Date 08/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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