QZA and RS Dental Implant Systems— 510(k) K163640

Substantially Equivalent

Trinon Titanium GmbH

FDA 510(k) clearance K163640 for QZA and RS Dental Implant Systems, Substantially Equivalent on 2017-05-03. Applicant: Trinon Titanium GmbH.

Clearance details

Applicant: Trinon Titanium GmbH
Product code: Code DZE
Advisory panel: Dental
Date received: 2016-12-23
Decision date: 2017-05-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Karlsruhe, DE

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.