Product code KJJ
- Device name
- Cleanser, Root Canal
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250279 | RC-SwiftPrep | Belport Company, Inc., Gingi-Pak | 2025-07-02 |
| K241354 | Sealer Solvent | Inter-Med, Inc. | 2024-08-27 |
| K201785 | EPIEN Dental Cleanser | Epien Medical, Inc. | 2021-09-09 |
| K211813 | Triton | Inter-Med / Vista Dental | 2021-08-18 |
| K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020-10-23 |
| K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020-09-09 |
| K200330 | RC-Prime Root Canal Preparation Cream | Pac-Dent, Inc. | 2020-07-06 |
| K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | Ultradent Products, Inc. | 2018-02-09 |
| K162311 | Straumann PrefGel | Institut Straumann AG | 2017-03-07 |
| K160577 | PacEndo Chlorhexidine | Pac-Dent International, Inc. | 2016-07-25 |
| K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016-02-01 |
| K151852 | PacEndo Sodium Hyprochlorite | Pac-Dent International, Inc. | 2015-11-10 |
| K150020 | Irritrol, EDS Combo-Rinse | Essential Dental Systesm, Inc. | 2015-02-25 |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | Oculus Innovative Sciences | 2014-08-18 |
| K140846 | EDS COMBO-RINSE | Essential Dental Systems, Inc. | 2014-07-25 |
| K130180 | CLEANSER ROOT CANAL | Cerkamed Wojciech Pawlowski | 2013-10-03 |
| K123538 | EPIEN ROOT CANAL CLEANSER | Epien Medical, Inc. | 2013-02-01 |
| K112250 | CHX=CHX PLUS | Inter-Med, Inc. | 2011-10-28 |
| K103244 | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | Dentsply Intl., Inc. | 2011-02-14 |
| K082470 | SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA | Inter-Med, Inc. | 2009-04-03 |
| K072555 | EDTA PLUS | Essential Dental Systems, Inc. | 2007-12-13 |
| K070401 | ENDO-CHX | Essential Dental Systems, Inc. | 2007-07-11 |
| K063812 | STRAUMANN PREFGEL | Straumann USA | 2007-01-12 |
| K063703 | CITRIC ACID 20% SOLUTION, MODEL 329 | Ultradent Products, Inc. | 2006-12-21 |
| K061689 | AQUATINE EC ENDODONTIC CLEANSER | Puricore, Inc. | 2006-08-24 |
| K060335 | FILE-EZE | Ultradent Products, Inc. | 2006-02-24 |
| K053167 | BIOPURE MTAD ROOT CANAL CLEANSER | Dentsply Intl., Inc. | 2005-12-08 |
| K032361 | ENDOPURE ROOT CANAL CLEANSER | Dentsply Intl. | 2004-01-12 |
| K032627 | ULTRADENT CITRIC ACID 10% SOLUTION | Ultradent Products, Inc. | 2003-11-12 |
| K030884 | APTUS BLUE | Acadental | 2003-05-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10818207024920 | Endo Sealer Solvent | Vista Dental | 2026-04-22 |
| 10818207024944 | Endo Sealer Solvent Sample | Vista Dental | 2026-04-22 |
| 00840326420386 | Young PerioDT | Young Innovations, Inc. | 2023-10-05 |
| 00840326420362 | Young PerioDT | Young Innovations, Inc. | 2023-10-05 |
| 00840326420348 | Young PerioDT | Young Innovations, Inc. | 2023-10-05 |
| 00840326420324 | Young PerioDT | Young Innovations, Inc. | 2023-10-05 |
| 00371347008098 | Advance Dental Products | The Atlanta Dental Supply Company | 2022-12-08 |
| 00850015491115 | Endocyn Root Canal Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2022-12-02 |
| D716BP288L1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BPSYRNDL21 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP48R1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP48P1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP48L1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP36SYS1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP36P1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP36L1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP288R1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP288P1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP156SYS1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP156P1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| D716BP156L1 | BioPure | TULSA DENTAL PRODUCTS LLC | 2022-10-13 |
| 10818207020649 | EDTA 4oz Bottle | Vista Dental | 2021-01-29 |
| 10818207020632 | SmearOFF 4oz Bottle | Vista Dental | 2021-01-29 |
| 10818207020625 | SmearOFF 16oz Bottle | Vista Dental | 2021-01-29 |
| 10818207020571 | EDTA 16oz Bottle | Vista Dental | 2021-01-29 |
| 10818207020564 | 1.2mL Unit Dose EDTA Kit | Vista Dental | 2021-01-21 |
| D661600111610 | CanalPro | COLTENE/WHALEDENT INC | 2019-02-26 |
| D661600111600 | CanalPro | COLTENE/WHALEDENT INC | 2019-02-26 |
| 00366975032829 | GIBSON HEALTHCARE | BENCO DENTAL SUPPLY CO. | 2018-09-19 |
| D661600139940 | CanalPro | COLTENE/WHALEDENT INC | 2016-06-21 |