Clearance Summary
SOPIX INSIDE, SOPIX2 INSIDE received FDA 510(k) clearance under submission number K140013, 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 2014-09-05.
- Submission: K140013
- Applicant / Sponsor: Sopro - Acteon Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2014-09-05
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.