Clearance Summary
Evoblock, Perléon received FDA 510(k) clearance under submission number K243621, sponsored by Evoden Indústria Comércio Importação E Exportação. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-04-22.
- Submission: K243621
- Applicant / Sponsor: Evoden Indústria Comércio Importação E Exportação
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2025-04-22
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.