Clearance Summary
Southern Craniomaxillofacial (CMF) System received FDA 510(k) clearance under submission number K253373, sponsored by Southern Medical (Pty) , 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 2025-12-19.
- Submission: K253373
- Applicant / Sponsor: Southern Medical (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code JEY and 21 CFR 872.4760, within the Dental review panel as a Class II device.