# K120659: HU-Friedy Dental Cartridge Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Hu-Friedy Mfg. Co., LLC
- Decided: Nov 6, 2012 after 246 days
- Product code: EJI (Syringe, Cartridge)
- Device class: 2
- Regulation: 21 CFR 872.6770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Henke-Sass Wolf Cartridge Syringes (Pre-amendment): named in the summary without a submission number

## Indications for use
These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Source page: https://510kreport.com/device/K120659
Methodology: https://510kreport.com/methodology