BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)


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

Correspodent Contact ester battilana
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 12/10/2007
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