Anker Dental Implant System - SB-III, ST and AT series— 510(k) K142557

Substantially Equivalent

Alliance Global Technology Co., Ltd.

FDA 510(k) clearance K142557 for Anker Dental Implant System - SB-III, ST and AT series, Substantially Equivalent on 2015-09-21. Applicant: Alliance Global Technology Co., Ltd..

Clearance details

Applicant: Alliance Global Technology Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2014-09-11
Decision date: 2015-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung 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.