# K043322: Miramatic Safe Syringe System

- Pathway: 510(k) (Traditional)
- Applicant: Hager Worldwide, Inc.
- Decided: Jul 21, 2005 after 231 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: 2 generations back to K913573 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022959: Safestep Safety Dental Cartridge Injector, Model 33-00000-1, MDC Research, Ltd. (2003) Summary page 1.

## Indications for use
Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues. The cartridge syringe may aid in the reduction of needle stick injuries.

Source page: https://510kreport.com/device/K043322
Methodology: https://510kreport.com/methodology