Cleared Traditional

K140846 - EDS COMBO-RINSE (FDA 510(k) Clearance)

K140846 · Essential Dental Systems, Inc. · Dental device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -