510(k) clearance
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
- 510(k) number
- K260137
- Applicant
- KLS-Martin L.P.
- Decision date
- Aug 17, 2026
- Date received
- Jan 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JEY
- Device type
- Plate, Bone
- Device class
- Class II
- Regulation
- 21 CFR 872.4760
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Jacksonville, FL, US