I-ROOT 100— 510(k) K112508

Name: FDA 510(k) clearance K112508
Creator: U.S. Food and Drug Administration
Published: 2012-06-19

Substantially Equivalent

S-Denti Co., Ltd.

FDA 510(k) clearance K112508 for I-ROOT 100, Substantially Equivalent on 2012-06-19. Applicant: S-Denti Co., Ltd.. Device class: Unclassified.

Clearance details

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

Download summary PDF View on FDA.gov ↗

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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.