Leforte MMF System— 510(k) K252246
Substantially EquivalentJeil Medical Corporation
FDA 510(k) clearance K252246 for Leforte MMF System, Substantially Equivalent on 2026-04-02. Applicant: Jeil Medical Corporation. Device class: 2.
Summary
Jeil Medical's Leforte MMF System is filed under product code JEY (Plate, Bone). The record doesn't spell out MMF or describe the system beyond its name and that code name.
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).
Jeil Medical filed from Seoul, South Korea. The decision came 258 calendar days after FDA received it (July 18, 2025 to April 2, 2026).
Clearance details
- Applicant
- Jeil Medical Corporation
- 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
- Seoul, KR
Recent devices under product code JEY
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- K253206 — METICULY Patient-specific CMF solution
- K253373 — Southern Craniomaxillofacial (CMF) System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)
More clearances from Jeil Medical Corporation
view allAdverse 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.