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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 K073458
Device Name BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)
Applicant
Btlock Srl
Via Madonnetta 97/C
36075 Montecchio Maggiore
Vicenza,  IT 36075
Applicant Contact ESTER BATTILANA
Correspondent
Btlock Srl
Via Madonnetta 97/C
36075 Montecchio Maggiore
Vicenza,  IT 36075
Correspondent Contact ESTER BATTILANA
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/10/2007
Decision Date 04/04/2008
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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