Clearance Summary
Disposable Prophy Angle received FDA 510(k) clearance under submission number K240950, sponsored by Pacific Care Limited. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-05-28.
- Submission: K240950
- Applicant / Sponsor: Pacific Care Limited
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2025-05-28
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.