# K171254: LeEject 2 Dental Syringe and Needle System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology and Capital, Inc.
- Decided: Nov 16, 2017 after 202 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
Longest line of descent: 4 generations back to K802483 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083796: Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating Syringe, Miltex Lightweight, Miltex, Inc. (2009) Summary page 4.
- (no number) Denject Disposable Dental Needles: named in the summary without a submission number

## Indications for use
“The LeEject 2 Syringe and Needle System is indicated to be used in conjunction with LeEject Needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.”

Source page: https://510kreport.com/device/K171254
Methodology: https://510kreport.com/methodology