# K113247: Anesthesia Injection Tool Set

- Pathway: 510(k) (Traditional)
- Applicant: Ki Works Co., Ltd.
- Decided: Mar 27, 2012 after 146 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: 1 generation back to K002387 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002387: Comfort Control Syringe System, Dentsply Intl. (2000) Summary page 3.

## Indications for use
The device is indicated for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures.

Source page: https://510kreport.com/device/K113247
Methodology: https://510kreport.com/methodology