TruMatch CMF Titanium 3D Printed Implant System— 510(k) K170272

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K170272 for TruMatch CMF Titanium 3D Printed Implant System, Substantially Equivalent on 2017-08-08. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code JEY
Advisory panel: Dental
Date received: 2017-01-30
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.