# K022959: Safestep Safety Dental Cartridge Injector, Model 33-00000-1

- Pathway: 510(k) (Traditional)
- Applicant: MDC Research, Ltd.
- Decided: Feb 5, 2003 after 152 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 K913573 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913573: Safety Plus Dental Injection Needle, Specialites Septodont (1991) Summary page 1.

## Most influential descendants
- K043322: Miramatic Safe Syringe System (2005), 0 descendants of its own

## Indications for use
The SafeStepTM Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStepTM Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStepTM Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.

Source page: https://510kreport.com/device/K022959
Methodology: https://510kreport.com/methodology