K260137
- 510(k) number
- K260137
- Device name
- 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
- Applicant
- KLS-Martin L.P. FL · US
- Product code
- JEY — Plate, Bone
- Decision date
- 2026-08-17
- Date received
- 2026-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260137.pdf
Official FDA record: K260137
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.