Cleared Traditional

K103244 - QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION

K103244 · Dentsply Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
104d
Days
-
Risk

K103244 is an FDA 510(k) clearance for the QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Dentsply Intl., Inc. (York, US). The FDA issued a Cleared decision on February 14, 2011 after a review of 104 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 Dentsply Intl., Inc. devices

FDA 510(k) Submission Details - K103244

510(k) Number K103244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2010
Decision Date February 14, 2011
Days to Decision 104 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
23d faster than avg
Panel avg: 127d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 34
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K103244.
CLEANSER ROOT CANAL
K130180 · Cerkamed Wojciech Pawlowski · Oct 2013
EPIEN ROOT CANAL CLEANSER
K123538 · Epien Medical, Inc. · Feb 2013
CHX=CHX PLUS
K112250 · Inter-Med, Inc. · Oct 2011
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
K082470 · Inter-Med, Inc. · Apr 2009
EDTA PLUS
K072555 · Essential Dental Systems, Inc. · Dec 2007
ENDO-CHX
K070401 · Essential Dental Systems, Inc. · Jul 2007