Clearance Summary
Dentis SQ-SL AXEL Fixture received FDA 510(k) clearance under submission number K253493, sponsored by Dentis 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 2026-03-04.
- Submission: K253493
- Applicant / Sponsor: Dentis Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2026-03-04
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.