Cleared Traditional

K140846 - EDS COMBO-RINSE

K140846 · Essential Dental Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
113d
Days
-
Risk

K140846 is an FDA 510(k) clearance for the EDS COMBO-RINSE. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Essential Dental Systems, Inc. (South Hackensack, US). The FDA issued a Cleared decision on July 25, 2014 after a review of 113 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 Essential Dental Systems, Inc. devices

FDA 510(k) Submission Details - K140846

510(k) Number K140846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2014
Decision Date July 25, 2014
Days to Decision 113 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
15d faster than avg
Panel avg: 128d · This submission: 113d
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 35
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K140846.
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ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K141352 · Oculus Innovative Sciences · Aug 2014
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