ET Hybrid Abutment— 510(k) K162390

Substantially Equivalent

Hiossen, Inc.

FDA 510(k) clearance K162390 for ET Hybrid Abutment, Substantially Equivalent on 2017-01-30. Applicant: Hiossen, Inc..

Clearance details

Applicant: Hiossen, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2016-08-26
Decision date: 2017-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fariless Hills, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.