Clearance Summary
Eagle S/Saevo Slim/D700 Slim received FDA 510(k) clearance under submission number K230732, sponsored by Alliage S/A Industrias Medica Odontológico.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-04-11.
- Submission: K230732
- Applicant / Sponsor: Alliage S/A Industrias Medica Odontológico.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2023-04-11
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.