Cleared Traditional

IROOT 100 MINI (K112153) - FDA 510(k) Clearance

K112153 · S-Denti Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
294d
Days
-
Risk

K112153 is an FDA 510(k) clearance for the IROOT 100 MINI. Classified as Locator, Root Apex (product code LQY).

Submitted by S-Denti Co., Ltd. (Pittsburgh, US). The FDA issued a Cleared decision on April 26, 2012 after a review of 294 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 K112153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2011
Decision Date April 26, 2012
Days to Decision 294 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
167d slower than avg
Panel avg: 127d · This submission: 294d
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 K112153.
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Root Apex Locator
K212178 · Foshan Coxo Medical Instrument Co., Ltd. · Jul 2022