Blue Sky Bio, LLC
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories4
Latest Approval2024-04-03
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | NXC | 2024-04-03 | View |
| 510(k) | K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | NXC | 2023-02-24 | View |
| 510(k) | K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | DZE | 2022-06-30 | View |
| 510(k) | K202026 | Blue Sky Bio CAD-CAM Abutments | NHA | 2020-12-18 | View |
| 510(k) | K201919 | Blue Sky Bio TAD | OAT | 2020-12-17 | View |
| 510(k) | K190491 | Blue Sky Bio Zygomatic Implant System | NHA | 2019-08-12 | View |
| 510(k) | K180107 | Blue Sky Bio Aligner | NXC | 2018-02-09 | View |
| 510(k) | K153064 | Blue Sky Bio Zygomatic Implant System | DZE | 2016-04-29 | View |
No matching devices.