The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, S.l. with the FDA for Bti Sterile Dental Drills Kit, Bti Abutments And Caps.
| Device ID | K061383 |
| 510k Number | K061383 |
| Device Name: | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS |
| Classification | Bur, Dental |
| Applicant | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. PARQUE TECNOLOGICO DE ALAVA LEONARDO DA VINCI 14B Minano(alava), ES 01510 |
| Contact | Leyre Z Hernando |
| Correspondent | Leyre Z Hernando B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. PARQUE TECNOLOGICO DE ALAVA LEONARDO DA VINCI 14B Minano(alava), ES 01510 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-18 |
| Decision Date | 2006-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08435389820024 | K061383 | 000 |
| 08435389813071 | K061383 | 000 |
| 08435389813064 | K061383 | 000 |
| 08435389813057 | K061383 | 000 |
| 08435389812470 | K061383 | 000 |
| 08435389812463 | K061383 | 000 |
| 08435389812456 | K061383 | 000 |
| 08435389804529 | K061383 | 000 |
| 08435389804512 | K061383 | 000 |
| 08435389804505 | K061383 | 000 |
| 08435389804499 | K061383 | 000 |
| 08435389804314 | K061383 | 000 |
| 08435389804307 | K061383 | 000 |
| 08435389804291 | K061383 | 000 |
| 08435389804161 | K061383 | 000 |
| 08435389804154 | K061383 | 000 |
| 08435389804147 | K061383 | 000 |
| 08435389815655 | K061383 | 000 |
| 08435389815662 | K061383 | 000 |
| 08435389815679 | K061383 | 000 |
| 08435389818595 | K061383 | 000 |
| 08435389818182 | K061383 | 000 |
| 08435389818175 | K061383 | 000 |
| 08435389817758 | K061383 | 000 |
| 08435389817741 | K061383 | 000 |
| 08435389817352 | K061383 | 000 |
| 08435389817345 | K061383 | 000 |
| 08435389817338 | K061383 | 000 |
| 08435389817321 | K061383 | 000 |
| 08435389817307 | K061383 | 000 |
| 08435389817291 | K061383 | 000 |
| 08435389817284 | K061383 | 000 |
| 08435389816713 | K061383 | 000 |
| 08435389815709 | K061383 | 000 |
| 08435389815693 | K061383 | 000 |
| 08435389815686 | K061383 | 000 |
| 08435389804130 | K061383 | 000 |