VisionX 2.4— 510(k) K192743

Substantially Equivalent

Durr Dental SE

FDA 510(k) clearance K192743 for VisionX 2.4, Substantially Equivalent on 2019-10-31. Applicant: Durr Dental SE.

Clearance details

Applicant: Durr Dental SE
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-09-30
Decision date: 2019-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bietigheim-Bissingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.