I-ROOT— 510(k) K100450

Substantially Equivalent

S-Denti Co., Ltd.

FDA 510(k) clearance K100450 for I-ROOT, Substantially Equivalent on 2010-11-18. Applicant: S-Denti Co., Ltd..

Clearance details

Applicant: S-Denti Co., Ltd.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2010-02-17
Decision date: 2010-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-City, Seoul, KR

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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.