Product Code: KJJ FDA unclassified

Cleanser, Root Canal

Unknown

Root Canal Cleanser is a dental device used during endodontic treatment to irrigate, dissolve organic debris, and disinfect the root canal system, removing pulp tissue remnants and microorganisms to prepare the canal for filling and sealing. This device is currently unclassified by the FDA, meaning it has not been placed into a risk class through the standard classification process, and a 510(k) submission has been required pending classification. The product code is KJJ; no regulation number or medical specialty code has been assigned.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code KJJ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: KJJ
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250279	RC-SwiftPrep	Jul 02, 2025	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K241354	Sealer Solvent	Aug 27, 2024	Substantially Equivalent	Inter-Med, Inc.
K201785	EPIEN Dental Cleanser	Sep 09, 2021	Substantially Equivalent	Epien Medical, Inc.
K211813	Triton	Aug 18, 2021	Substantially Equivalent	Inter-Med / Vista Dental
K193357	V-Mix	Oct 23, 2020	Substantially Equivalent	Inter-Med/Vista Dental Products
K193409	Vista Rinse, Vista Rinse Plus	Sep 09, 2020	Substantially Equivalent	Inter-Med/Vista Dental Products
K200330	RC-Prime Root Canal Preparation Cream	Jul 06, 2020	Substantially Equivalent	Pac-Dent, Inc.
K173163	ChlorCid, ChlorCid V, ChlorCid Surf	Feb 09, 2018	Substantially Equivalent	Ultradent Products, Inc.
K162311	Straumann PrefGel	Mar 07, 2017	Substantially Equivalent	Institut Straumann AG
K160577	PacEndo Chlorhexidine	Jul 25, 2016	Substantially Equivalent	Pac-Dent International, Inc.
K153528	PacEndo EDTA	Feb 01, 2016	Substantially Equivalent	Pac-Dent International, Inc.
K151852	PacEndo Sodium Hyprochlorite	Nov 10, 2015	Substantially Equivalent	Pac-Dent International, Inc.
K150020	Irritrol, EDS Combo-Rinse	Feb 25, 2015	Substantially Equivalent	Essential Dental Systesm, Inc.
K141352	ENDOCYN ROOT CANAL IRRIGATION SOLUTION	Aug 18, 2014	Substantially Equivalent	Oculus Innovative Sciences
K140846	EDS COMBO-RINSE	Jul 25, 2014	Substantially Equivalent	Essential Dental Systems, Inc.
K130180	CLEANSER ROOT CANAL	Oct 03, 2013	Substantially Equivalent	Cerkamed Wojciech Pawlowski
K123538	EPIEN ROOT CANAL CLEANSER	Feb 01, 2013	Substantially Equivalent	Epien Medical, Inc.
K112250	CHX=CHX PLUS	Oct 28, 2011	Substantially Equivalent	Inter-Med, Inc.
K103244	QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION	Feb 14, 2011	Substantially Equivalent	Dentsply Intl., Inc.
K082470	SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA	Apr 03, 2009	Substantially Equivalent	Inter-Med, Inc.
K072555	EDTA PLUS	Dec 13, 2007	Substantially Equivalent	Essential Dental Systems, Inc.
K070401	ENDO-CHX	Jul 11, 2007	Substantially Equivalent	Essential Dental Systems, Inc.
K063812	STRAUMANN PREFGEL	Jan 12, 2007	Substantially Equivalent	Straumann USA
K063703	CITRIC ACID 20% SOLUTION, MODEL 329	Dec 21, 2006	Substantially Equivalent	Ultradent Products, Inc.
K061689	AQUATINE EC ENDODONTIC CLEANSER	Aug 24, 2006	Substantially Equivalent	Puricore, Inc.
K060335	FILE-EZE	Feb 24, 2006	Substantially Equivalent	Ultradent Products, Inc.
K053167	BIOPURE MTAD ROOT CANAL CLEANSER	Dec 08, 2005	Substantially Equivalent	Dentsply Intl., Inc.
K032361	ENDOPURE ROOT CANAL CLEANSER	Jan 12, 2004	Substantially Equivalent	Dentsply Intl.
K032627	ULTRADENT CITRIC ACID 10% SOLUTION	Nov 12, 2003	Substantially Equivalent	Ultradent Products, Inc.
K030884	APTUS BLUE	May 27, 2003	Substantially Equivalent	Acadental
K024198	SMEARCLEAR	Mar 05, 2003	Substantially Equivalent	Sybron Dental Specialties, Inc.
K003422	EDTA ROOT CANAL CLEANSER	Jan 19, 2001	Substantially Equivalent	Super Glide, Inc.
K992919	OXY-GLIDE ROOT CANAL CLEANSER & LUB.	Nov 19, 1999	Substantially Equivalent	Super Glide, Inc.
K992484	RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG	Oct 14, 1999	Substantially Equivalent	Jordco, Inc.
K962743	PULPDENT SODIUM HYPOCHLORITE SOLUTION	Aug 06, 1996	Substantially Equivalent	Pulpdent Corp.
K950365	MOYCO-EDTA	Apr 27, 1995	Substantially Equivalent	Union Broach, Div. Moyco Industries, Inc.
K934415	FILE-EZE	Apr 13, 1994	Substantially Equivalent	Ultradent Products, Inc.
K921713	DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT	Nov 04, 1993	Substantially Equivalent	A and V Ent.
K830814	POINT, PAPER ENDODONTIC	Apr 06, 1983	Substantially Equivalent	Endodent, Inc.
K802853	CLEANSER, ROOT CANAL	Dec 18, 1980	Substantially Equivalent	Dentsply Intl.
K780003	ENDOSOLV E	Jan 20, 1978	Substantially Equivalent	Septodont, Inc.