DeviceClearance

KLS Martin IPS Oral-Max Implants - MR Conditional +3 more— 510(k) K260137

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K260137 for KLS Martin IPS Oral-Max Implants - MR Conditional +3 more, Substantially Equivalent on 2026-08-17. Applicant: KLS-Martin L.P.. Device class: 2.

Summary

KLS-Martin's submission lists KLS Martin IPS Oral-Max Implants (MR Conditional), Individual Patient Solutions in Ti (IPS-Ti) and PEEK (IPS-PEEK) versions, and KLS Martin Individual Patient Solutions. The product code is JEY, bone plates.

Class II, 21 CFR 872.4760. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).

KLS-Martin filed from Jacksonville, Florida. The substantially equivalent decision came 213 calendar days after receipt (January 16 to August 17, 2026).

Clearance details

Device name as filed
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.
Product code
Product code JEY
Device class
Class 2
Regulation
21 CFR 872.4760
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jacksonville, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JEY

product code JEY
Injury
1,542
Malfunction
2,292
Total
3,834

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.