The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, S.l. with the FDA for Bti Dental Implant System Unicca.
| Device ID | K173257 |
| 510k Number | K173257 |
| Device Name: | BTI Dental Implant System UnicCa |
| Classification | Implant, Endosseous, Root-form |
| Applicant | B.T.I. Biotechnology Institute, S.L. Leaonardo Da Vinci 14 Parque Tecnologico De Alava Minano, ES 01510 |
| Contact | Fernanda O Ros |
| Correspondent | Fernanda O Ros B.T.I. Biotechnology Institute, S.L. Leaonardo Da Vinci 14 Parque Tecnologico De Alava Minano, ES 01510 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-10 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435389811985 | K173257 | 000 |
| 08435389811480 | K173257 | 000 |
| 08435389811497 | K173257 | 000 |
| 08435389811527 | K173257 | 000 |
| 08435389811534 | K173257 | 000 |
| 08435389811541 | K173257 | 000 |
| 08435389811558 | K173257 | 000 |
| 08435389811565 | K173257 | 000 |
| 08435389811596 | K173257 | 000 |
| 08435389811602 | K173257 | 000 |
| 08435389811923 | K173257 | 000 |
| 08435389811930 | K173257 | 000 |
| 08435389811947 | K173257 | 000 |
| 08435389811978 | K173257 | 000 |
| 08435389811473 | K173257 | 000 |