The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, S.l. with the FDA for Bti Endosseous Dental Implant Angled Abutments.
| Device ID | K070533 |
| 510k Number | K070533 |
| Device Name: | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI, 14 B Minano Menor, Alava, ES 01510 |
| Contact | ;eyre Z Hernando |
| Correspondent | ;eyre Z Hernando B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI, 14 B Minano Menor, Alava, 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 | 2007-02-26 |
| Decision Date | 2007-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435389808169 | K070533 | 000 |
| 08435389805403 | K070533 | 000 |
| 08435389805410 | K070533 | 000 |
| 08435389805427 | K070533 | 000 |
| 08435389805434 | K070533 | 000 |
| 08435389805441 | K070533 | 000 |
| 08435389805458 | K070533 | 000 |
| 08435389805465 | K070533 | 000 |
| 08435389805472 | K070533 | 000 |
| 08435389807124 | K070533 | 000 |
| 08435389807131 | K070533 | 000 |
| 08435389807841 | K070533 | 000 |
| 08435389807858 | K070533 | 000 |
| 08435389807926 | K070533 | 000 |
| 08435389807933 | K070533 | 000 |
| 08435389808152 | K070533 | 000 |
| 08435389805397 | K070533 | 000 |