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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 K123415
Device Name BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
Applicant
Biodenta Swiss AG
Tramstrasse 16
Berneck, St.Gallen,  CH 9442
Applicant Contact DAVID EILER
Correspondent
Biodenta Swiss AG
Tramstrasse 16
Berneck, St.Gallen,  CH 9442
Correspondent Contact DAVID EILER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/05/2012
Decision Date 03/19/2013
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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