Clearance Summary
SOPIX received FDA 510(k) clearance under submission number K142995, sponsored by Sopro - Acteon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-08-17.
- Submission: K142995
- Applicant / Sponsor: Sopro - Acteon Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2015-08-17
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.