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 |