FDA 510(k) Applications for Medical Device Product Code "KJJ"
(Cleanser, Root Canal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K030884 | ACADENTAL | APTUS BLUE | 05/27/2003 |
| K130180 | CERKAMED WOJCIECH PAWLOWSKI | CLEANSER ROOT CANAL | 10/03/2013 |
| K032361 | DENTSPLY INTL. | ENDOPURE ROOT CANAL CLEANSER | 01/12/2004 |
| K053167 | DENTSPLY INTL., INC. | BIOPURE MTAD ROOT CANAL CLEANSER | 12/08/2005 |
| K103244 | DENTSPLY INTL., INC. | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | 02/14/2011 |
| K201785 | EPIEN Medical, Inc. | EPIEN Dental Cleanser | 09/09/2021 |
| K123538 | EPIEN MEDICAL, INC. | EPIEN ROOT CANAL CLEANSER | 02/01/2013 |
| K140846 | ESSENTIAL DENTAL SYSTEMS, INC. | EDS COMBO-RINSE | 07/25/2014 |
| K072555 | ESSENTIAL DENTAL SYSTEMS, INC. | EDTA PLUS | 12/13/2007 |
| K070401 | ESSENTIAL DENTAL SYSTEMS, INC. | ENDO-CHX | 07/11/2007 |
| K150020 | ESSENTIAL DENTAL SYSTESM, INC. | Irritrol, EDS Combo-Rinse | 02/25/2015 |
| K162311 | INSTITUT STRAUMANN AG | Straumann PrefGel | 03/07/2017 |
| K211813 | Inter-Med / Vista Dental | Triton | 08/18/2021 |
| K112250 | INTER-MED, INC. | CHX=CHX PLUS | 10/28/2011 |
| K082470 | INTER-MED, INC. | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | 04/03/2009 |
| K193357 | Inter-Med/ Vista Dental Products | V-Mix | 10/23/2020 |
| K193409 | Inter-Med/Vista Dental Products | Vista Rinse, Vista Rinse Plus | 09/09/2020 |
| K992484 | JORDCO, INC. | RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG | 10/14/1999 |
| K141352 | OCULUS INNOVATIVE SCIENCES | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | 08/18/2014 |
| K160577 | PAC-DENT INTERNATIONAL, INC. | PacEndo Chlorhexidine | 07/25/2016 |
| K153528 | PAC-DENT INTERNATIONAL, INC. | PacEndo EDTA | 02/01/2016 |
| K151852 | PAC-DENT INTERNATIONAL, INC. | PacEndo Sodium Hyprochlorite | 11/10/2015 |
| K200330 | Pac-Dent, Inc | RC-Prime Root Canal Preparation Cream | 07/06/2020 |
| K962743 | PULPDENT CORP. | PULPDENT SODIUM HYPOCHLORITE SOLUTION | 08/06/1996 |
| K061689 | PURICORE, INC. | AQUATINE EC ENDODONTIC CLEANSER | 08/24/2006 |
| K063812 | STRAUMANN USA | STRAUMANN PREFGEL | 01/12/2007 |
| K003422 | SUPER GLIDE, INC. | EDTA ROOT CANAL CLEANSER | 01/19/2001 |
| K992919 | SUPER GLIDE, INC. | OXY-GLIDE ROOT CANAL CLEANSER & LUB. | 11/19/1999 |
| K024198 | SYBRON DENTAL SPECIALTIES, INC. | SMEARCLEAR | 03/05/2003 |
| K173163 | Ultradent Products, Inc. | ChlorCid, ChlorCid V, ChlorCid Surf | 02/09/2018 |
| K063703 | ULTRADENT PRODUCTS, INC. | CITRIC ACID 20% SOLUTION, MODEL 329 | 12/21/2006 |
| K060335 | ULTRADENT PRODUCTS, INC. | FILE-EZE | 02/24/2006 |
| K032627 | ULTRADENT PRODUCTS, INC. | ULTRADENT CITRIC ACID 10% SOLUTION | 11/12/2003 |
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