Cleared Traditional

NAVI ROOT (K083901) - FDA 510(k) Clearance

K083901 · S-Denti Co., Ltd. · Dental device
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Apr 2009
Decision
107d
Days
-
Risk

K083901 is an FDA 510(k) clearance for the NAVI ROOT. Classified as Locator, Root Apex (product code LQY).

Submitted by S-Denti Co., Ltd. (Greenwood Village, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all S-Denti Co., Ltd. devices

Submission Details

510(k) Number K083901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date April 15, 2009
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 45
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K083901.
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Apex Locator
K231990 · Cefla S.C. · Feb 2024
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · Changzhou Haili Medical Co., Ltd. · Dec 2023
Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022