HC-BIOS DENTAL IMPLANT— 510(k) K110425

Substantially Equivalent

Hung Chun Bio-S Co., Ltd.

FDA 510(k) clearance K110425 for HC-BIOS DENTAL IMPLANT, Substantially Equivalent on 2012-07-27. Applicant: Hung Chun Bio-S Co., Ltd..

Clearance details

Applicant: Hung Chun Bio-S Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2011-02-14
Decision date: 2012-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.