Clearance Summary
KLS Martin IPS Preprosthetic received FDA 510(k) clearance under submission number K210228, 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 2022-07-08.
- Submission: K210228
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3645
- Decision date: 2022-07-08
Classification & Regulation
This clearance is catalogued under FDA product code ELE and 21 CFR 872.3645, within the Dental review panel as a Class II device.