Qmix 2IN1 Endodontic Irrigating Solution
FDA 510(k) K103244 · Dentsply Intl., Inc.
510(k) numberK103244
Submission
- Device name
- Qmix 2IN1 Endodontic Irrigating Solution
- Applicant
- Dentsply Intl., Inc.
York, PA, US - Received
- November 2, 2010
- Decision date
- February 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KJJ – Cleanser, Root Canal
- Device class
- Unclassified
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| K250279 | RC-SwiftPrepKJJ · Traditional | Belport Company, Inc., Gingi-Pak | 07/02/2025SE |
| K241354 | Sealer SolventKJJ · Traditional | Inter-Med, Inc. | 08/27/2024SE |
| K201785 | EPIEN Dental CleanserKJJ · Traditional | Epien Medical, Inc. | 09/09/2021SE |
| K211813 | TritonKJJ · Special | Inter-Med / Vista Dental | 08/18/2021SE |
| K193357 | V-MixKJJ · Traditional | Inter-Med/Vista Dental Products | 10/23/2020SE |
| K193409 | Vista Rinse, Vista Rinse PlusKJJ · Traditional | Inter-Med/Vista Dental Products | 09/09/2020SE |
| K200330 | RC-Prime Root Canal Preparation CreamKJJ · Traditional | Pac-Dent, Inc. | 07/06/2020SE |
| K173163 | ChlorCid, ChlorCid V, ChlorCid SurfKJJ · Traditional | Ultradent Products, Inc. | 02/09/2018SE |
| K162311 | Straumann PrefGelKJJ · Traditional | Institut Straumann AG | 03/07/2017SE |
| K160577 | PacEndo ChlorhexidineKJJ · Traditional | Pac-Dent International, Inc. | 07/25/2016SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
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| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
| K070538 | XP Bond Dual Cure Universal Total Etch AdhesiveKLE · Special | 03/14/2007SE |
Questions and answers
When was Qmix 2IN1 Endodontic Irrigating Solution cleared by the FDA?
Qmix 2IN1 Endodontic Irrigating Solution (K103244) received a 510(k) decision of Substantially Equivalent on February 14, 2011, 104 days after the submission was received.
What is the product code of K103244?
The FDA product code is KJJ – Cleanser, Root Canal, a Unclassified device.