Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KJJ — Predicate Candidate Screening

41 FDA 510(k) clearances under this product code; the 50 most recent screened below.

86 daysmedian FDA review time

251 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K250279	RC-SwiftPrep	Belport Company, Inc., Gingi-Pak	2025-07-02	152	0
K241354	Sealer Solvent	Inter-Med, Inc.	2024-08-27	106	0
K201785	EPIEN Dental Cleanser	Epien Medical, Inc.	2021-09-09	436	0
K211813	Triton	Inter-Med / Vista Dental	2021-08-18	68	0
K193357	V-Mix	Inter-Med/Vista Dental Products	2020-10-23	324	0
K193409	Vista Rinse, Vista Rinse Plus	Inter-Med/Vista Dental Products	2020-09-09	275	0
K200330	RC-Prime Root Canal Preparation Cream	Pac-Dent, Inc.	2020-07-06	147	0
K173163	ChlorCid, ChlorCid V, ChlorCid Surf	Ultradent Products, Inc.	2018-02-09	133	0
K162311	Straumann PrefGel	Institut Straumann AG	2017-03-07	201	0
K160577	PacEndo Chlorhexidine	Pac-Dent International, Inc.	2016-07-25	146	0
K153528	PacEndo EDTA	Pac-Dent International, Inc.	2016-02-01	54	0
K151852	PacEndo Sodium Hyprochlorite	Pac-Dent International, Inc.	2015-11-10	126	0
K150020	Irritrol, EDS Combo-Rinse	Essential Dental Systesm, Inc.	2015-02-25	50	0
K141352	ENDOCYN ROOT CANAL IRRIGATION SOLUTION	Oculus Innovative Sciences	2014-08-18	87	0
K140846	EDS COMBO-RINSE	Essential Dental Systems, Inc.	2014-07-25	113	0
K130180	CLEANSER ROOT CANAL	Cerkamed Wojciech Pawlowski	2013-10-03	251	0
K123538	EPIEN ROOT CANAL CLEANSER	Epien Medical, Inc.	2013-02-01	77	0
K112250	CHX=CHX PLUS	Inter-Med, Inc.	2011-10-28	85	0
K103244	QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION	Dentsply Intl., Inc.	2011-02-14	104	0
K082470	SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGEN	Inter-Med, Inc.	2009-04-03	219	7
K072555	EDTA PLUS	Essential Dental Systems, Inc.	2007-12-13	94	0
K070401	ENDO-CHX	Essential Dental Systems, Inc.	2007-07-11	149	0
K063812	STRAUMANN PREFGEL	Straumann USA	2007-01-12	21	0
K063703	CITRIC ACID 20% SOLUTION, MODEL 329	Ultradent Products, Inc.	2006-12-21	8	0
K061689	AQUATINE EC ENDODONTIC CLEANSER	Puricore, Inc.	2006-08-24	70	0
K060335	FILE-EZE	Ultradent Products, Inc.	2006-02-24	15	0
K053167	BIOPURE MTAD ROOT CANAL CLEANSER	Dentsply Intl., Inc.	2005-12-08	24	0
K032361	ENDOPURE ROOT CANAL CLEANSER	Dentsply Intl.	2004-01-12	165	0
K032627	ULTRADENT CITRIC ACID 10% SOLUTION	Ultradent Products, Inc.	2003-11-12	78	0
K030884	APTUS BLUE	Acadental	2003-05-27	68	0
K024198	SMEARCLEAR	Sybron Dental Specialties, Inc.	2003-03-05	75	0
K003422	EDTA ROOT CANAL CLEANSER	Super Glide, Inc.	2001-01-19	77	0
K992919	OXY-GLIDE ROOT CANAL CLEANSER & LUB.	Super Glide, Inc.	1999-11-19	81	0
K992484	RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG	Jordco, Inc.	1999-10-14	80	0
K962743	PULPDENT SODIUM HYPOCHLORITE SOLUTION	Pulpdent Corp.	1996-08-06	22	0
K950365	MOYCO-EDTA	Union Broach, Div. Moyco Industries, Inc.	1995-04-27	86	0
K934415	FILE-EZE	Ultradent Products, Inc.	1994-04-13	215	0
K921713	DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT	A and V Ent.	1993-11-04	576	0
K830814	POINT, PAPER ENDODONTIC	Endodent, Inc.	1983-04-06	22	0
K802853	CLEANSER, ROOT CANAL	Dentsply Intl.	1980-12-18	35	0
K780003	ENDOSOLV E	Septodont, Inc.	1978-01-20	22	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda