The following data is part of a premarket notification filed by Btlock Srl with the FDA for Bt-tite One(bticv1), Bt-tite Standard(btivsm), Bt-tite Cv2(bticv2).
| Device ID | K073458 |
| 510k Number | K073458 |
| Device Name: | BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BTLOCK SRL VIA MADONNETTA 97/C 36075 MONTECCHIO MAGGIORE Vicenza, IT 36075 |
| Contact | Ester Battilana |
| Correspondent | Ester Battilana BTLOCK SRL VIA MADONNETTA 97/C 36075 MONTECCHIO MAGGIORE Vicenza, IT 36075 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-10 |
| Decision Date | 2008-04-04 |
| Summary: | summary |