Clearance Summary
iOrtho received FDA 510(k) clearance under submission number K223518, sponsored by Shanghai EA Medical Instruments Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-06-13.
- Submission: K223518
- Applicant / Sponsor: Shanghai EA Medical Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2023-06-13
Classification & Regulation
This clearance is catalogued under FDA product code PNN and 21 CFR 872.5470, within the Dental review panel as a Class II device.