510(k) · Cleared
ClearedSafestep Safety Dental Cartridge Injector, Model 33-00000-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MDC Research, Ltd. · EJI Syringe, Cartridge
Cleared on Feb 5, 2003 as substantially equivalent to K913573 (Specialites Septodont, 1991) after a 152-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Feb 5, 2003
- Review
- 152 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913573 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK913573 Safety Plus Dental Injection NeedleSpecialites Septodont · 1991
- This deviceK022959 Safestep Safety Dental Cartridge Injector, Model 33-00000-1MDC Research, Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK043322 Miramatic Safe Syringe SystemHager Worldwide, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K043322Miramatic Safe Syringe SystemHager Worldwide, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913573 | Safety Plus Dental Injection Needle | Specialites Septodont | 1991 | — |
| 0 (this device) | K022959 | Safestep Safety Dental Cartridge Injector, Model 33-00000-1 | MDC Research, Ltd. | 2003 | — |
| +1 | K043322 | Miramatic Safe Syringe System | Hager Worldwide, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913573 | Safety Plus Dental Injection NeedleSummary page 1…DEVICE ComDanv 51Otk) No. Date Cleared Specialties Septodont Safety Plus Dental K913573 11/07/91 Needle System 16.4 DEVICE DESCRIPTION The SafeStepTMSafety Dent… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043322 | Miramatic Safe Syringe System | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K043322 (Hager Worldwide, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EJI devicesEJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EJI
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EJI
No recall names EJI since 2007.
Adverse event reports per year · EJI
1in 2025
MAUDE reports naming product code EJI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 3 | 78 | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022959: Safestep Safety Dental Cartridge Injector, Model 33-00000-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022959
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026