Clearance Summary
Livento Press, Soprano 10, Soprano received FDA 510(k) clearance under submission number K192251, sponsored by Cendres+Metaux SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-01-15.
- Submission: K192251
- Applicant / Sponsor: Cendres+Metaux SA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2020-01-15
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.