Cleared Traditional

K112508 - I-ROOT 100

K112508 · S-Denti Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
294d
Days
-
Risk

K112508 is an FDA 510(k) clearance for the I-ROOT 100. Classified as Locator, Root Apex (product code LQY).

Submitted by S-Denti Co., Ltd. (Tae Kye Nam, KR). The FDA issued a Cleared decision on June 19, 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.

FDA 510(k) Submission Details - K112508

510(k) Number K112508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2011
Decision Date June 19, 2012
Days to Decision 294 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
166d slower than avg
Panel avg: 128d · This submission: 294d
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
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Download PDF FDA Summary S-Denti Co., Ltd.