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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 K103577
Device Name TRINON Q & Q3 IMPLANT SYSTEM
Applicant
Trinon Titanium GmbH
Schwarzwaldstrasse 5
Tuttlingen,  DE 78576
Applicant Contact MARKUS DENK
Correspondent
Trinon Titanium GmbH
Schwarzwaldstrasse 5
Tuttlingen,  DE 78576
Correspondent Contact MARKUS DENK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/06/2010
Decision Date 07/03/2012
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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