Ti-one 101 TS Dental Implant System— 510(k) K172821

Substantially Equivalent

Hung Chun Bio-S Co., Ltd.

FDA 510(k) clearance K172821 for Ti-one 101 TS Dental Implant System, Substantially Equivalent on 2018-06-11. 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: 2017-09-18
Decision date: 2018-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung, 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.