NAVI ROOT— 510(k) K083901

Substantially Equivalent

S-Denti Co., Ltd.

FDA 510(k) clearance K083901 for NAVI ROOT, Substantially Equivalent on 2009-04-15. Applicant: S-Denti Co., Ltd..

Clearance details

Applicant: S-Denti Co., Ltd.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2008-12-29
Decision date: 2009-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

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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.