NR Line Implant System— 510(k) K153268

Substantially Equivalent

Dentium Co., Ltd.

FDA 510(k) clearance K153268 for NR Line Implant System, Substantially Equivalent on 2016-07-20. Applicant: Dentium Co., Ltd..

Clearance details

Applicant: Dentium Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2015-11-12
Decision date: 2016-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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.