Atlas FDA

KJJ

41 FDA 510(k) clearances · Product code

86 daysmedian time to decision
251 days90th percentile
41clearances measured

FDA profile

Official device name
Cleanser, Root Canal
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1994: 1 · 2006: 2 · 2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
RC-SwiftPrep (K250279)Belport Company, Inc., Gingi-Pak2025-07-02
Sealer Solvent (K241354)Inter-Med, Inc.2024-08-27
EPIEN Dental Cleanser (K201785)Epien Medical, Inc.2021-09-09
Triton (K211813)Inter-Med / Vista Dental2021-08-18
V-Mix (K193357)Inter-Med/Vista Dental Products2020-10-23
Vista Rinse, Vista Rinse Plus (K193409)Inter-Med/Vista Dental Products2020-09-09
RC-Prime Root Canal Preparation Cream (K200330)Pac-Dent, Inc.2020-07-06
ChlorCid, ChlorCid V, ChlorCid Surf (K173163)Ultradent Products, Inc.2018-02-09
Straumann PrefGel (K162311)Institut Straumann AG2017-03-07
PacEndo Chlorhexidine (K160577)Pac-Dent International, Inc.2016-07-25
PacEndo EDTA (K153528)Pac-Dent International, Inc.2016-02-01
PacEndo Sodium Hyprochlorite (K151852)Pac-Dent International, Inc.2015-11-10
Irritrol, EDS Combo-Rinse (K150020)Essential Dental Systesm, Inc.2015-02-25
ENDOCYN ROOT CANAL IRRIGATION SOLUTION (K141352)Oculus Innovative Sciences2014-08-18
EDS COMBO-RINSE (K140846)Essential Dental Systems, Inc.2014-07-25
CLEANSER ROOT CANAL (K130180)Cerkamed Wojciech Pawlowski2013-10-03
EPIEN ROOT CANAL CLEANSER (K123538)Epien Medical, Inc.2013-02-01
CHX=CHX PLUS (K112250)Inter-Med, Inc.2011-10-28
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (K103244)Dentsply Intl., Inc.2011-02-14
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA (K082470)Inter-Med, Inc.2009-04-03
EDTA PLUS (K072555)Essential Dental Systems, Inc.2007-12-13
ENDO-CHX (K070401)Essential Dental Systems, Inc.2007-07-11
STRAUMANN PREFGEL (K063812)Straumann USA2007-01-12
CITRIC ACID 20% SOLUTION, MODEL 329 (K063703)Ultradent Products, Inc.2006-12-21
AQUATINE EC ENDODONTIC CLEANSER (K061689)Puricore, Inc.2006-08-24
FILE-EZE (K060335)Ultradent Products, Inc.2006-02-24
BIOPURE MTAD ROOT CANAL CLEANSER (K053167)Dentsply Intl., Inc.2005-12-08
ENDOPURE ROOT CANAL CLEANSER (K032361)Dentsply Intl.2004-01-12
ULTRADENT CITRIC ACID 10% SOLUTION (K032627)Ultradent Products, Inc.2003-11-12
APTUS BLUE (K030884)Acadental2003-05-27
SMEARCLEAR (K024198)Sybron Dental Specialties, Inc.2003-03-05
EDTA ROOT CANAL CLEANSER (K003422)Super Glide, Inc.2001-01-19
OXY-GLIDE ROOT CANAL CLEANSER & LUB. (K992919)Super Glide, Inc.1999-11-19
RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG (K992484)Jordco, Inc.1999-10-14
PULPDENT SODIUM HYPOCHLORITE SOLUTION (K962743)Pulpdent Corp.1996-08-06
MOYCO-EDTA (K950365)Union Broach, Div. Moyco Industries, Inc.1995-04-27
FILE-EZE (K934415)Ultradent Products, Inc.1994-04-13
DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT (K921713)A and V Ent.1993-11-04
POINT, PAPER ENDODONTIC (K830814)Endodent, Inc.1983-04-06
CLEANSER, ROOT CANAL (K802853)Dentsply Intl.1980-12-18
ENDOSOLV E (K780003)Septodont, Inc.1978-01-20

Track KJJ automatically

Every clearance here is in the API, with alerts when new ones post.