ETIII SA Fixture System (O3.2mm)— 510(k) K153332

Substantially Equivalent

Hiossen, Inc.

FDA 510(k) clearance K153332 for ETIII SA Fixture System (O3.2mm), Substantially Equivalent on 2016-10-27. Applicant: Hiossen, Inc..

Clearance details

Applicant: Hiossen, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2015-11-19
Decision date: 2016-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fariless Hills, PA, US

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.