LuxaPrint Ortho Plus— 510(k) K210940

Substantially Equivalent

Dmg Digital Enterprises SE

FDA 510(k) clearance K210940 for LuxaPrint Ortho Plus, Substantially Equivalent on 2021-09-03. Applicant: Dmg Digital Enterprises SE.

Clearance details

Applicant: Dmg Digital Enterprises SE
Product code: Code MQC
Advisory panel: Unknown
Date received: 2021-03-29
Decision date: 2021-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.