MedCAD® AccuPlate® Patient-Specific Plate— 510(k) K193280

Substantially Equivalent

Medcad

FDA 510(k) clearance K193280 for MedCAD® AccuPlate® Patient-Specific Plate, Substantially Equivalent on 2021-02-12. Applicant: Medcad.

Clearance details

Applicant: Medcad
Product code: Code JEY
Advisory panel: Dental
Date received: 2019-11-27
Decision date: 2021-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

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.