Clearance Summary
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) received FDA 510(k) clearance under submission number K223446, sponsored by Signifier Medical Technologies, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-01-18.
- Submission: K223446
- Applicant / Sponsor: Signifier Medical Technologies, Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5575
- Decision date: 2023-01-18
Classification & Regulation
This clearance is catalogued under FDA product code QNO and 21 CFR 872.5575, within the Dental review panel as a Class II device.