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 5.5-6.5.
| Device ID | K091387 |
| 510k Number | K091387 |
| Device Name: | BTI DENTAL IMPLANT 5.5-6.5 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI 14 B Minano(alava), ES 01510 |
| Contact | Alfredo Gomez |
| Correspondent | Alfredo Gomez B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI 14 B Minano(alava), 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 | 2009-05-11 |
| Decision Date | 2010-01-22 |
| Summary: | summary |