Brass Nick Impres Tray/Amalgam Car/Syrin Cart/Arti
FDA 510(k) K926121 · Dentmed , Ltd.
510(k) numberK926121
Submission
- Device name
- Brass Nick Impres Tray/Amalgam Car/Syrin Cart/Arti
- Applicant
- Dentmed , Ltd.
Alexandria, VA, US - Received
- December 3, 1992
- Decision date
- February 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…EJI · Traditional | Miltex, Inc. | 03/09/2009SE |
| K081694 | DenjectorEJI · Traditional | Dxm Co., Ltd. | 09/12/2008SE |
| K061904 | Compudent StaEJI · Traditional | Milestone Scientific, Inc. | 08/08/2006SE |
| K043322 | Miramatic Safe Syringe SystemEJI · Traditional | Hager Worldwide, Inc. | 07/21/2005SE |
More from Hager Worldwide, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921071 | DentolockKOB · Traditional | 03/26/1992SE |
Questions and answers
When was Brass Nick Impres Tray/Amalgam Car/Syrin Cart/Arti cleared by the FDA?
Brass Nick Impres Tray/Amalgam Car/Syrin Cart/Arti (K926121) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 427 days after the submission was received.
What is the product code of K926121?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.