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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 K133733
Device Name WINSIX Implant System
Applicant
Biosaf IN S.R.L.
Via A. Altobelli Bonetti 3/A
Imola,  IT 40026
Applicant Contact MAURIZIO PANTALEONI
Correspondent
Biosaf IN S.R.L.
Via A. Altobelli Bonetti 3/A
Imola,  IT 40026
Correspondent Contact MAURIZIO PANTALEONI
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/06/2013
Decision Date 01/28/2015
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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