METICULY Patient-specific CMF solution

Q: What is the product code of K253206?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.

FDA 510(k) K253206 · Meticuly Co., Ltd.

Substantially Equivalent

510(k) numberK253206

Submission

Device name: METICULY Patient-specific CMF solution
Applicant: Meticuly Co., Ltd.
Bangkok, TH
Received: September 26, 2025
Decision date: July 25, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JEY – Plate, Bone
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.4760
Specialty: Dental
Implant: Yes

Other 510(k)s with product code JEY

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K253373	Southern Craniomaxillofacial (CMF) SystemJEY · Traditional	Southern Medical (Pty) , Ltd.	12/19/2025SE
K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional	Inion OY	11/07/2025SE
K241314	KLS Martin Oral-Max Implants MR Conditional (bundled)JEY · Traditional	KLS-Martin L.P.	08/16/2024SE
K240651	MRI UniversalJEY · Traditional	Stryker Leibinger GmbH & Co KG	07/12/2024SE
K233874	tmCMF SolutionJEY · Traditional	Techmah Cmf	07/11/2024SE
K232889	METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional	Meticuly Co., Ltd.	04/30/2024SE
K232350	Stryker Facial iD SystemJEY · Traditional	Stryker Craniomaxillofacial	01/13/2024SE
K230398	MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY · Traditional	Medcad	09/26/2023SE

More from Medcad

510(k)	Device	Decision
K252958	METICULY Patient-specific titanium mesh implantGXN · Traditional	01/14/2026SE
K232889	METICULY Patient-specific titanium maxillofacial mesh implantJEY · Traditional	04/30/2024SE
K210099	Meticuly Patient-Specific Titanium Mesh ImplantGXN · Traditional	12/21/2021SE

Questions and answers

When was METICULY Patient-specific CMF solution cleared by the FDA?

METICULY Patient-specific CMF solution (K253206) received a 510(k) decision of Substantially Equivalent on July 25, 2026, 302 days after the submission was received.

What is the product code of K253206?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.