Clearance Summary
Bioliner received FDA 510(k) clearance under submission number K182658, sponsored by Five Star Orthodontic Lab & Supply. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-06-19.
- Submission: K182658
- Applicant / Sponsor: Five Star Orthodontic Lab & Supply
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2019-06-19
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.