KJJ

FDA Product Code KJJ: Cleanser, Root Canal

Leading manufacturers include Ultradent Products, Inc., Essential Dental Systems, Inc. and Pac-Dent International, Inc..

41
Total
41
Cleared
125d
Avg days
1978
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 152d recently vs 125d historically

FDA 510(k) Cleared Cleanser, Root Canal Devices (Product Code KJJ)

41 devices
1–24 of 41
Cleared Jul 02, 2025
RC-SwiftPrep
K250279
Belport Company, Inc., Gingi-Pak
Dental · 152d
Cleared Aug 27, 2024
Sealer Solvent
K241354
Inter-Med, Inc.
Dental · 106d
Cleared Sep 09, 2021
EPIEN Dental Cleanser
K201785
Epien Medical, Inc.
Dental · 436d
Cleared Aug 18, 2021
Triton
K211813
Inter-Med / Vista Dental
Dental · 68d
Cleared Oct 23, 2020
V-Mix
K193357
Inter-Med/Vista Dental Products
Dental · 324d
Cleared Sep 09, 2020
Vista Rinse, Vista Rinse Plus
K193409
Inter-Med/Vista Dental Products
Dental · 275d
Cleared Jul 06, 2020
RC-Prime Root Canal Preparation Cream
K200330
Pac-Dent, Inc.
Dental · 147d
Cleared Feb 09, 2018
ChlorCid, ChlorCid V, ChlorCid Surf
K173163
Ultradent Products, Inc.
Dental · 133d
Cleared Mar 07, 2017
Straumann PrefGel
K162311
Institut Straumann AG
Dental · 201d
Cleared Jul 25, 2016
PacEndo Chlorhexidine
K160577
Pac-Dent International, Inc.
Dental · 146d
Cleared Feb 01, 2016
PacEndo EDTA
K153528
Pac-Dent International, Inc.
Dental · 54d
Cleared Nov 10, 2015
PacEndo Sodium Hyprochlorite
K151852
Pac-Dent International, Inc.
Dental · 126d
Cleared Feb 25, 2015
Irritrol, EDS Combo-Rinse
K150020
Essential Dental Systesm, Inc.
Dental · 50d
Cleared Aug 18, 2014
ENDOCYN ROOT CANAL IRRIGATION SOLUTION
K141352
Oculus Innovative Sciences
Dental · 87d
Cleared Jul 25, 2014
EDS COMBO-RINSE
K140846
Essential Dental Systems, Inc.
Dental · 113d
Cleared Oct 03, 2013
CLEANSER ROOT CANAL
K130180
Cerkamed Wojciech Pawlowski
Dental · 251d
Cleared Feb 01, 2013
EPIEN ROOT CANAL CLEANSER
K123538
Epien Medical, Inc.
Dental · 77d
Cleared Oct 28, 2011
CHX=CHX PLUS
K112250
Inter-Med, Inc.
Dental · 85d
Cleared Feb 14, 2011
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
K103244
Dentsply Intl., Inc.
Dental · 104d
Cleared Dec 13, 2007
EDTA PLUS
K072555
Essential Dental Systems, Inc.
Dental · 94d
Cleared Jul 11, 2007
ENDO-CHX
K070401
Essential Dental Systems, Inc.
Dental · 149d
Cleared Jan 12, 2007
STRAUMANN PREFGEL
K063812
Straumann USA
Dental · 21d
Cleared Dec 21, 2006
CITRIC ACID 20% SOLUTION, MODEL 329
K063703
Ultradent Products, Inc.
Dental · 8d
Cleared Aug 24, 2006
AQUATINE EC ENDODONTIC CLEANSER
K061689
Puricore, Inc.
Dental · 70d

About Product Code KJJ - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code KJJ since 1978, with 41 receiving FDA clearance (average review time: 125 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - KJJ Product Code

Recent submissions under KJJ have taken an average of 152 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.

KJJ devices are reviewed by the Dental panel. Browse all Dental devices →