Clearance Summary
Apoller Flow Light Cure Flowable Composite received FDA 510(k) clearance under submission number K180463, sponsored by Greenway Yw, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-11-14.
- Submission: K180463
- Applicant / Sponsor: Greenway Yw, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2018-11-14
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.