Chang Gung ComMed Series Dental Implant System— 510(k) K142751

Substantially Equivalent

Chang Gung Medical Technology Co., Ltd.

FDA 510(k) clearance K142751 for Chang Gung ComMed Series Dental Implant System, Substantially Equivalent on 2015-06-15. Applicant: Chang Gung Medical Technology Co., Ltd..

Clearance details

Applicant: Chang Gung Medical Technology Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2014-09-24
Decision date: 2015-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 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.