Clearance Summary
HEXIM Implant; Samwon General Abutments received FDA 510(k) clearance under submission number K243731, sponsored by P&A USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-07-09.
- Submission: K243731
- Applicant / Sponsor: P&A USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2025-07-09
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.