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TruMatch CMF Titanium 3D Printed Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173039

by Materialise NV

Identifiers

510(k) Number
K173039 FDA 510(k)
FDA Product Code
JEY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4760 FDA 510(k)
Regulation Number
872.4760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TruMatch CMF Titanium 3D Printed Implant by Materialise NV — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA 510(k) K173039 24 fields · synced Jun 18, 2026