Henke-Ject Pressure Syringe (Modification)
510(k) K864294
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864294 | Date4 Nov 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EGM
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4475
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Henke-Ject Pressure Syringe (Modification) is a mechanical-powered jet injector classified as a dental injector. This device delivers substances under pressure via a jet stream, designed for precision application in dental procedures. It operates without traditional needle penetration, reducing patient discomfort and potential infection risks. The device is intended for use in dental settings where controlled fluid delivery is required.
The Henke-Ject Pressure Syringe (Modification) is supplied as a reusable device and is regulated under FDA 510(k) clearance (K864294) with a classification of Class II. It is intended for dental applications and falls under the product code EGM. The device’s mechanical design ensures consistent pressure delivery, and its use is governed by dental practice standards. No specific sterility or MRI safety information is provided in the available data.