Blue Sky Bio Zygomatic Implant System — Blue Sky Bio, LLC (510(k) K190491)
Blue Sky Bio Zygomatic Implant System — Blue Sky Bio, LLC (510(k) K190491) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Blue Sky Bio Zygomatic Implant System; Applicant: Blue Sky Bio, LLC; Clearance track: 510(k).
| Device name | Blue Sky Bio Zygomatic Implant System |
|---|---|
| Applicant | Blue Sky Bio, LLC |
| Clearance track | 510(k) |
| Submission number | K190491 |
| Decision | Substantially Equivalent |
| Decision date | 2019-08-12 |
| Date received | 2019-02-28 |
| Product code | NHA |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | IL, US |
| Source | openFDA device |
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$1999/mo
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