510(k) K112508— I-ROOT 100

Substantially Equivalent

S-Denti Co., Ltd.

Clearance details

Applicant: S-Denti Co., Ltd.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2011-08-30
Decision date: 2012-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tae Kye Nam, KR

Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

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.