The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, S.l. with the FDA for Bti Extra-short Dental Implant System Unicca.
| Device ID | K202825 |
| 510k Number | K202825 |
| Device Name: | BTI Extra-Short 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 | Jose Roman Rivero |
| Correspondent | Jose Roman Rivero 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 | 2020-09-24 |
| Decision Date | 2021-07-29 |