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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 K163640
Device Name QZA and RS Dental Implant Systems
Applicant
Trinon Titanium GmbH
Augartenstr. 1
Karlsruhe,  DE 76137
Applicant Contact Katja Lvova
Correspondent
Trinon Titanium GmbH
Augartenstr. 1
Karlsruhe,  DE 76137
Correspondent Contact Katja Lvova
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/23/2016
Decision Date 05/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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