Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX— 510(k) K232653
Substantially EquivalentBlue Sky Bio, LLC
FDA 510(k) clearance K232653 for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX, Substantially Equivalent on 2024-04-03. Applicant: Blue Sky Bio, LLC.
Clearance details
- Applicant
- Blue Sky Bio, LLC
- Product code
- Code NXC
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Adverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.