Cleared Traditional

K153528 - PacEndo EDTA

K153528 · Pac-Dent International, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
54d
Days
-
Risk

K153528 is an FDA 510(k) clearance for the PacEndo EDTA. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Pac-Dent International, Inc. (Brea, US). The FDA issued a Cleared decision on February 1, 2016 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K153528

510(k) Number K153528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2015
Decision Date February 01, 2016
Days to Decision 54 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
74d faster than avg
Panel avg: 128d · This submission: 54d
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 36
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K153528.
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · Ultradent Products, Inc. · Feb 2018
Straumann PrefGel
K162311 · Institut Straumann AG · Mar 2017
PacEndo Chlorhexidine
K160577 · Pac-Dent International, Inc. · Jul 2016
PacEndo Sodium Hyprochlorite
K151852 · Pac-Dent International, Inc. · Nov 2015
Irritrol, EDS Combo-Rinse
K150020 · Essential Dental Systesm, Inc. · Feb 2015
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K141352 · Oculus Innovative Sciences · Aug 2014