Cleared Traditional

K100450 - I-ROOT

K100450 · S-Denti Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K100450

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 128d · This submission: 274d
Pathway characteristics
Predicate-based equivalence.

LQY Device Classification - Class 0,

Product Code LQY Locator, Root Apex
Device Class -

Regulatory Peers - LQY Locator, Root Apex

All 42
Devices cleared under the same product code (LQY) and FDA review panel - the closest regulatory comparables to K100450.
IROOT 100 MINI
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K101177 · Medicnrg , Ltd. · Oct 2010
ROMIAPEX MODEL A-15
K101054 · Romidan, Ltd. · Sep 2010
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · J. Morita USA, Inc. · Nov 2009
K100450 · I-ROOT
Download PDF FDA Summary S-Denti Co., Ltd.