The following data is part of a premarket notification filed by Btlock Srl with the FDA for Bt-tite Cv3, Mini Implant, Mini Single, Slot Implant, Model(s) Dddiii Bticv3, 1, And Dddiiibtisi.
| Device ID | K083869 |
| 510k Number | K083869 |
| Device Name: | BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BTLOCK SRL VIA MADONNETTA 97/C Montecchio Maggiore, Vicenza, IT 36075 |
| Contact | Esther Battilana |
| Correspondent | Esther Battilana BTLOCK SRL VIA MADONNETTA 97/C Montecchio Maggiore, Vicenza, IT 36075 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-03-27 |
| Summary: | summary |