510(k) K260137

KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions by KLS-Martin L.P. — Product Code JEY

K260137 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions". The FDA issued a decision of Substantially Equivalent on August 17, 2026. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.