OssBuilder System— 510(k) K181854

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K181854 for OssBuilder System, Substantially Equivalent on 2019-05-07. Applicant: Osstem Implant Co., Ltd..

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code DZL
Advisory panel: Dental
Date received: 2018-07-11
Decision date: 2019-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.