Z5-TL— 510(k) K201712

Substantially Equivalent

Z-Systems AG

FDA 510(k) clearance K201712 for Z5-TL, Substantially Equivalent on 2020-12-01. Applicant: Z-Systems AG.

Clearance details

Applicant: Z-Systems AG
Product code: Code DZE
Advisory panel: Dental
Date received: 2020-06-23
Decision date: 2020-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oensingen, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.