The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, Sl. with the FDA for Bti Interna Dental Implant System Unicca - Prosthetic Components.
| Device ID | K213106 |
| 510k Number | K213106 |
| Device Name: | BTI Interna Dental Implant System UnicCa - Prosthetic Components |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | B.T.I. Biotechnology Institute, SL. Leonardo Da Vinci 14, Parque Technologico De Alava Minano, ES 01510 |
| Contact | Jose Ramon Rivero |
| Correspondent | Jose Ramon Rivero B.T.I. Biotechnology Institute, SL. Leonardo Da Vinci 14, Parque Technologico De Alava Minano, ES 01510 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-24 |
| Decision Date | 2022-10-20 |