EGM · Injector, Jet, Mechanical-Powered
Dental · 21 CFR 872.4475 · Class 2
Overview
| Product Code | EGM |
|---|---|
| Device Name | Injector, Jet, Mechanical-Powered |
| Regulation | 21 CFR 872.4475 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.
Classification Rationale
Class II.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243427 | QuickSleeper 5 | Dentalhitec | Aug 1, 2025 | SESE |
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | W&H Dentalwerk Buermoos GmbH | Jan 14, 2010 | SESE |
| K964802 | CYBERJET LOCAL ANESTHESIA SYSTEM | Intra Vantage, Inc. | May 27, 1997 | SESE |
| K962017 | HYPODERMIC JET INJECTION APPARATUS | American Jet Injector Corp. | Jul 26, 1996 | SESE |
| K904279 | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. | Dec 7, 1990 | SESE |
| K864294 | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | Smith & Nephew, Inc. | Nov 4, 1987 | SESE |
| K864732 | GRADTECH SYRINGE SYSTEM | Gradtech | Apr 15, 1987 | SESE |
| K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. | Feb 13, 1987 | SESE |
| K834361 | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. | Mar 5, 1984 | SESE |
| K821273 | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. | May 28, 1982 | SESE |
| K790193 | MIZZY SYRIJET MARK IV | Mizzy, Inc. | Apr 23, 1979 | SESE |
Top Applicants
- W&H Dentalwerk Buermoos GmbH — 1 clearance
- Smith & Nephew, Inc. — 1 clearance
- Ronvig Instruments, Ltd. — 1 clearance
- Mizzy, Inc. — 1 clearance
- Intra Vantage, Inc. — 1 clearance
