DBSWIN, VISTAEASY— 510(k) K203287

Substantially Equivalent

Dürr Dental SE

FDA 510(k) clearance K203287 for DBSWIN, VISTAEASY, Substantially Equivalent on 2020-11-18. Applicant: Dürr Dental SE.

Clearance details

Applicant: Dürr Dental SE
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-11-09
Decision date: 2020-11-18
Decision: Substantially Equivalent
Clearance type: Special
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.