Cleared Traditional

TruMatch CMF Titanium 3D Printed Implant

K173039 · Materialise NV · Dental
Jul 2018
Decision
285d
Days
Class 2
Risk

About This 510(k) Submission

K173039 is an FDA 510(k) clearance for the TruMatch CMF Titanium 3D Printed Implant, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on July 10, 2018, 285 days after receiving the submission on September 28, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K173039 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2017
Decision Date July 10, 2018
Days to Decision 285 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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