The following data is part of a premarket notification filed by Leone Spa with the FDA for Leone Orthodontic Mini Implant.
| Device ID | K071490 |
| 510k Number | K071490 |
| Device Name: | LEONE ORTHODONTIC MINI IMPLANT |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | LEONE SPA 50, VIA P. A QUARACCHI Sesto, Fiorentino, IT I-50019 |
| Contact | Elia Ladani |
| Correspondent | Elia Ladani LEONE SPA 50, VIA P. A QUARACCHI Sesto, Fiorentino, IT I-50019 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-30 |
| Decision Date | 2008-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033707096320 | K071490 | 000 |
| 08033707071570 | K071490 | 000 |
| 08033707071563 | K071490 | 000 |
| 08033707071556 | K071490 | 000 |
| 08033707071549 | K071490 | 000 |
| 08033707071532 | K071490 | 000 |
| 08033707071501 | K071490 | 000 |
| 08033707071495 | K071490 | 000 |
| 08033707071488 | K071490 | 000 |
| 08033707071471 | K071490 | 000 |
| 08033707071464 | K071490 | 000 |
| 08033707071587 | K071490 | 000 |
| 08033707071617 | K071490 | 000 |
| 08033707096313 | K071490 | 000 |
| 08033707092513 | K071490 | 000 |
| 08033707092506 | K071490 | 000 |
| 08033707071686 | K071490 | 000 |
| 08033707071679 | K071490 | 000 |
| 08033707071662 | K071490 | 000 |
| 08033707071655 | K071490 | 000 |
| 08033707071648 | K071490 | 000 |
| 08033707071631 | K071490 | 000 |
| 08033707071624 | K071490 | 000 |
| 08033707071457 | K071490 | 000 |