Cleared Traditional

I-ROOT (K100450) - FDA 510(k) Clearance

K100450 · S-Denti Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
274d
Days
-
Risk

K100450 is an FDA 510(k) clearance for the I-ROOT. Classified as Locator, Root Apex (product code LQY).

Submitted by S-Denti Co., Ltd. (Seongnam-City, Seoul, KR). The FDA issued a Cleared decision on November 18, 2010 after a review of 274 days - an extended review cycle.

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 K100450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date November 18, 2010
Days to Decision 274 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 127d · This submission: 274d
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 K100450.
Apex Locator (FindPex)
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Apex Locator
K242383 · Shenzhen Rogin Medical Co., Ltd. · Mar 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Jan 2025
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