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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 K083869
Device Name BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI
Applicant
Btlock Srl
Via Madonnetta 97/C
Montecchio Maggiore, Vicenza,  IT 36075
Applicant Contact ESTHER BATTILANA
Correspondent
Btlock Srl
Via Madonnetta 97/C
Montecchio Maggiore, Vicenza,  IT 36075
Correspondent Contact ESTHER BATTILANA
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/29/2008
Decision Date 03/27/2009
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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