Surgical devices · 21 CFR 872 Subpart E
Mechanical-Powered Jet Injector
FDA device type “Injector, Jet, Mechanical-Powered”.
- Companies listing it
- 33 makers
- Brands and models
- 2
- 510(k) clearances
- 111 in five years
- FDA name
- Injector, Jet, Mechanical-Powered
510(k) clearances per year, 1976–2026
Companies that list EGM
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dental Hi Tec | France | Maker | QuickSleeper5 | 1 | 2025 |
| Ronvig Dental Mfg. A/S | Denmark | Maker | PAROJECT | 1 | 2006 |
| Mada Medical Products, Inc. | United States | Maker | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 Aug 2025 | K243427 | QuickSleeper 5 | Dental Hi Tec |
| 14 Jan 2010 | K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | W&H Dentalwerk Buermoos GmbH |
| 27 May 1997 | K964802 | CYBERJET LOCAL ANESTHESIA SYSTEM | Intra Vantage, Inc. |
| 26 Jul 1996 | K962017 | HYPODERMIC JET INJECTION APPARATUS | American Jet Injector Corp. |
| 7 Dec 1990 | K904279 | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. |
| 4 Nov 1987 | K864294 | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | Smith & Nephew, Inc. |
| 15 Apr 1987 | K864732 | GRADTECH SYRINGE SYSTEM | Gradtech |
| 13 Feb 1987 | K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. |
| 5 Mar 1984 | K834361 | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. |
| 28 May 1982 | K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. |
| 23 Apr 1979 | K790193 | MIZZY SYRIJET MARK IV | Mizzy, Inc. |
Official records: FDA product classification for EGM · 21 CFR 872.4475.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026