Blue Sky Bio Aligner— 510(k) K180107
Substantially EquivalentBlue Sky Bio, LLC
FDA 510(k) clearance K180107 for Blue Sky Bio Aligner, Substantially Equivalent on 2018-02-09. Applicant: Blue Sky Bio, LLC. Device class: 2.
Clearance details
- Applicant
- Blue Sky Bio, LLC
- Product code
- Code NXC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grayslake, IL, US
Recent devices under product code NXC
view allMore clearances from Blue Sky Bio, LLC
view all- K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
- K221845 — Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
- K212785 — Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
- K202026 — Blue Sky Bio CAD-CAM Abutments
- K201919 — Blue Sky Bio TAD
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.