KJJ

FDA Product Code KJJ: Cleanser, Root Canal

Leading manufacturers include Ultradent Products, Inc., Dentsply Intl. and Inter-Med/Vista Dental Products.

41
Total
41
Cleared
125d
Avg days
1978
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 129d avg (recent)

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 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 Feb 24, 2006
FILE-EZE
K060335
Ultradent Products, Inc.
Dental · 15d
Cleared Jan 12, 2004
ENDOPURE ROOT CANAL CLEANSER
K032361
Dentsply Intl.
Dental · 165d
Cleared Nov 12, 2003
ULTRADENT CITRIC ACID 10% SOLUTION
K032627
Ultradent Products, Inc.
Dental · 78d
Cleared Mar 05, 2003
SMEARCLEAR
K024198
Sybron Dental Specialties, Inc.
Dental · 75d
Cleared Aug 06, 1996
PULPDENT SODIUM HYPOCHLORITE SOLUTION
K962743
Pulpdent Corp.
Dental · 22d
Cleared Apr 13, 1994
FILE-EZE
K934415
Ultradent Products, Inc.
Dental · 215d
Cleared Dec 18, 1980
CLEANSER, ROOT CANAL
K802853
Dentsply Intl.
Dental · 35d

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 increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KJJ Product Code

FDA review times for KJJ submissions have been consistent, averaging 129 days recently vs 125 days historically.

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