METICULY Patient-specific CMF solution— 510(k) K253206

Clearance details

Applicant

Meticuly Co., Ltd.

Product code

Code JEY

Device class

Class 2

Regulation

21 CFR 872.4760

Advisory panel

Dental

Date received

2025-09-26

Decision date

2026-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bangkok, TH

• K252246 — Leforte MMF System2026-04-02
• K253373 — Southern Craniomaxillofacial (CMF) System2025-12-19
• K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System2025-11-07
• K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)2024-08-16
• K240651 — MRI Universal2024-07-12

• K252958 — METICULY Patient-specific titanium mesh implant2026-01-14
• K232889 — METICULY Patient-specific titanium maxillofacial mesh implant2024-04-30
• K210099 — Meticuly Patient-Specific Titanium Mesh Implant2021-12-21

Injury

1,542

Malfunction

2,292

Total

3,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →