Denjector
FDA 510(k) K081694 · Dxm Co., Ltd.
510(k) numberK081694
Submission
- Device name
- Denjector
- Applicant
- Dxm Co., Ltd.
Great Neck, NY, US - Received
- June 17, 2008
- Decision date
- September 12, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K171254 | LeEject 2 Dental Syringe and Needle SystemEJI · Traditional | Advanced Technology and Capital, Inc. | 11/16/2017SE |
| K142414 | Miltex N-Tralig Intraligamentary SyringeEJI · Special | Integra LifeSciences Corporation | 10/30/2014SE |
| K120659 | Hu-Friedy Dental Cartridge SyringeEJI · Traditional | Hu-Friedy Mfg. Co., LLC | 11/06/2012SE |
| K113247 | Anesthesia Injection Tool SetEJI · Traditional | Ki Works Co., Ltd. | 03/27/2012SE |
| K082249 | MorpheusEJI · Abbreviated | Meibach Tech Ltda | 12/31/2009SE |
| K092943 | Aspirating Syringe, Non-Aspirating SyringeEJI · Traditional | Arnold Tuber Industries | 12/11/2009SE |
| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…EJI · Traditional | Miltex, Inc. | 03/09/2009SE |
| K061904 | Compudent StaEJI · Traditional | Milestone Scientific, Inc. | 08/08/2006SE |
| K043322 | Miramatic Safe Syringe SystemEJI · Traditional | Hager Worldwide, Inc. | 07/21/2005SE |
| K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating SyringesEJI · Traditional | Anthogyr | 12/14/2004SE |
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Questions and answers
When was Denjector cleared by the FDA?
Denjector (K081694) received a 510(k) decision of Substantially Equivalent on September 12, 2008, 87 days after the submission was received.
What is the product code of K081694?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.