Clearance Summary
ZSmile System received FDA 510(k) clearance under submission number K253282, sponsored by Dror Orthodesign , 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 2026-02-03.
- Submission: K253282
- Applicant / Sponsor: Dror Orthodesign , Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2026-02-03
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.