# KJJ · Cleanser, Root Canal

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/KJJ

## Overview

- **Product Code:** KJJ
- **Device Name:** Cleanser, Root Canal
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 41)

Showing 20 most recent of 41 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250279](/device/K250279.md) | RC-SwiftPrep | Belport Company, Inc., Gingi-Pak | Jul 2, 2025 | SESE |
| [K241354](/device/K241354.md) | Sealer Solvent | Inter-Med, Inc. | Aug 27, 2024 | SESE |
| [K201785](/device/K201785.md) | EPIEN Dental Cleanser | Epien Medical, Inc. | Sep 9, 2021 | SESE |
| [K211813](/device/K211813.md) | Triton | Inter-Med / Vista Dental | Aug 18, 2021 | SESE |
| [K193357](/device/K193357.md) | V-Mix | Inter-Med/Vista Dental Products | Oct 23, 2020 | SESE |
| [K193409](/device/K193409.md) | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | Sep 9, 2020 | SESE |
| [K200330](/device/K200330.md) | RC-Prime Root Canal Preparation Cream | Pac-Dent, Inc. | Jul 6, 2020 | SESE |
| [K173163](/device/K173163.md) | ChlorCid, ChlorCid V, ChlorCid Surf | Ultradent Products, Inc. | Feb 9, 2018 | SESE |
| [K162311](/device/K162311.md) | Straumann PrefGel | Institut Straumann AG | Mar 7, 2017 | SESE |
| [K160577](/device/K160577.md) | PacEndo Chlorhexidine | Pac-Dent International, Inc. | Jul 25, 2016 | SESE |
| [K153528](/device/K153528.md) | PacEndo EDTA | Pac-Dent International, Inc. | Feb 1, 2016 | SESE |
| [K151852](/device/K151852.md) | PacEndo Sodium Hyprochlorite | Pac-Dent International, Inc. | Nov 10, 2015 | SESE |
| [K150020](/device/K150020.md) | Irritrol, EDS Combo-Rinse | Essential Dental Systesm, Inc. | Feb 25, 2015 | SESE |
| [K141352](/device/K141352.md) | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | Oculus Innovative Sciences | Aug 18, 2014 | SESE |
| [K140846](/device/K140846.md) | EDS COMBO-RINSE | Essential Dental Systems, Inc. | Jul 25, 2014 | SESE |
| [K130180](/device/K130180.md) | CLEANSER ROOT CANAL | Cerkamed Wojciech Pawlowski | Oct 3, 2013 | SESE |
| [K123538](/device/K123538.md) | EPIEN ROOT CANAL CLEANSER | Epien Medical, Inc. | Feb 1, 2013 | SESE |
| [K112250](/device/K112250.md) | CHX=CHX PLUS | Inter-Med, Inc. | Oct 28, 2011 | SESE |
| [K103244](/device/K103244.md) | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | Dentsply Intl., Inc. | Feb 14, 2011 | SESE |
| [K082470](/device/K082470.md) | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | Inter-Med, Inc. | Apr 3, 2009 | SESE |

## Top Applicants

- Ultradent Products, Inc. — 5 clearances
- Essential Dental Systems, Inc. — 3 clearances
- Inter-Med, Inc. — 3 clearances
- Pac-Dent International, Inc. — 3 clearances
- Dentsply Intl. — 2 clearances

---

**Source:** [https://fda.innolitics.com/productcode/KJJ](https://fda.innolitics.com/productcode/KJJ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com