Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4475](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4475) → EGM — Injector, Jet, Mechanical-Powered

# EGM · Injector, Jet, Mechanical-Powered

_Dental · 21 CFR 872.4475 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM

## Overview

- **Product Code:** EGM
- **Device Name:** Injector, Jet, Mechanical-Powered
- **Regulation:** [21 CFR 872.4475](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4475)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **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.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243427](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K243427.md) | QuickSleeper 5 | Dentalhitec | Aug 1, 2025 | SESE |
| [K083811](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K083811.md) | W&H HANDPIECE ANESTO, MODEL: RA-5 | W&H Dentalwerk Buermoos GmbH | Jan 14, 2010 | SESE |
| [K964802](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K964802.md) | CYBERJET LOCAL ANESTHESIA SYSTEM | Intra Vantage, Inc. | May 27, 1997 | SESE |
| [K962017](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K962017.md) | HYPODERMIC JET INJECTION APPARATUS | American Jet Injector Corp. | Jul 26, 1996 | SESE |
| [K904279](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K904279.md) | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. | Dec 7, 1990 | SESE |
| [K864294](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K864294.md) | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) | Smith & Nephew, Inc. | Nov 4, 1987 | SESE |
| [K864732](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K864732.md) | GRADTECH SYRINGE SYSTEM | Gradtech | Apr 15, 1987 | SESE |
| [K864861](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K864861.md) | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. | Feb 13, 1987 | SESE |
| [K834361](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K834361.md) | JSB JET SYRINGE | C.B.S. Biotechnics, Inc. | Mar 5, 1984 | SESE |
| [K821273](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K821273.md) | MAYO SCISSOR STRAIGHT 6 3/4 | Conphar, Inc. | May 28, 1982 | SESE |
| [K790193](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K790193.md) | MIZZY SYRIJET MARK IV | Mizzy, Inc. | Apr 23, 1979 | SESE |

## Top Applicants

- American Jet Injector Corp. — 1 clearance
- C.B.S. Biotechnics, Inc. — 1 clearance
- Conphar, Inc. — 1 clearance
- Dentalhitec — 1 clearance
- Gradtech — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM)

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