K253206
- 510(k) number
- K253206
- Device name
- METICULY Patient-specific CMF solution
- Applicant
- Meticuly Co., Ltd. TH
- Product code
- JEY — Plate, Bone
- Decision date
- 2026-07-25
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253206.pdf
Official FDA record: K253206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.