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 | K151391 |
| 510k Number | K151391 |
| Device Name: | BTI Dental Implant System UnicCa |
| Classification | Implant, Endosseous, Root-form |
| Applicant | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI 14, PARQUE TECNOLOGICO DE ALAVA Minano, ES 01510 |
| Contact | Fernanda Olabarria Ros |
| Correspondent | Fernanda Olabarria Ros B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO 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 | 2015-05-26 |
| Decision Date | 2016-05-02 |
| Summary: | summary |