Clearance Summary
Blue Sky Bio Aligner received FDA 510(k) clearance under submission number K180107, sponsored by Blue Sky Bio, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-02-09.
- Submission: K180107
- Applicant / Sponsor: Blue Sky Bio, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2018-02-09
Classification & Regulation
This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.