METICULY Patient-specific CMF solution— 510(k) K253206
Substantially EquivalentMeticuly Co., Ltd.
FDA 510(k) clearance K253206 for METICULY Patient-specific CMF solution, Substantially Equivalent on 2026-07-25. Applicant: Meticuly Co., Ltd.. Device class: 2.
Summary
Meticuly's METICULY Patient-specific CMF solution is filed under JEY, bone plates. The name says patient-specific, and the record doesn't expand "CMF" or give materials.
Class II, 21 CFR 872.4760. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
Meticuly filed from Bangkok, Thailand. Review took 302 calendar days (September 26, 2025 to July 25, 2026).
Clearance details
- Applicant
- Meticuly Co., Ltd.
- 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
- Bangkok, TH
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More clearances from Meticuly Co., Ltd.
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.