Clearance Summary
LOCATOR R-Tx received FDA 510(k) clearance under submission number K200827, sponsored by Ivory Super Holdco, Incp.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-09-02.
- Submission: K200827
- Applicant / Sponsor: Ivory Super Holdco, Incp.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2020-09-02
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.