Henke Ject Pressure Syringe

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K830524 ↗

FDA Product Code

EJI

Device Class

Class II

Regulation

21 CFR Part 872.6770

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K833304 Active Cleared 30 Mar 1984

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See all devices from Smith & Nephew, Mpl Division →

• What is the Henke Ject Pressure Syringe used for?

  The Henke Ject Pressure Syringe is designed specifically for dental use to inject anesthetic agents either subcutaneously or intramuscularly. Its pressure mechanism ensures controlled delivery of the anesthetic from a pre-filled glass cartridge, making it ideal for procedures requiring precise dosing in dental settings.

• How is the Henke Ject Pressure Syringe supplied?

  The device is supplied as a reusable metal syringe body paired with single-use, disposable glass cartridges (carpules) containing the anesthetic. This pairing allows for repeated use of the syringe body while ensuring each cartridge is used only once, maintaining sterility and safety.

• Is the Henke Ject Pressure Syringe sterile?

  The reusable metal syringe body is not sterile out-of-the-box and must be cleaned and sterilized between uses. The disposable glass cartridges, however, are pre-filled and intended for single-use, ensuring sterility for each anesthetic injection.

• Can the Henke Ject Pressure Syringe be reused?

  Yes, the metal syringe body of the Henke Ject Pressure Syringe is designed for reuse. However, it must be thoroughly cleaned and sterilized after each use to prevent contamination. The disposable glass cartridges are intended for single-use only and should not be reused.

• What regulatory approval does the Henke Ject Pressure Syringe have?

  The Henke Ject Pressure Syringe holds FDA 510(k) clearance (K830524) under the Dental advisory committee, classified as a Class II medical device. It was authorized for commercial distribution on March 24, 1983, and is regulated under FDA code 872.6770.