Clearance Summary
KLS Martin Individual Patient Solutions (IPS) Planning System received FDA 510(k) clearance under submission number K182789, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-03-11.
- Submission: K182789
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2019-03-11
Classification & Regulation
This clearance is catalogued under FDA product code DZJ and 21 CFR 872.4120, within the Dental review panel as a Class II device.