510(k) · Cleared
ClearedLeEject 2 Dental Syringe and Needle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology and Capital, Inc. · EJI Syringe, Cartridge
Cleared on Nov 16, 2017 as substantially equivalent to K083796 (Miltex, Inc., 2009) after a 202-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- Nov 16, 2017
- Review
- 202 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K802483 (1980). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK802483 LigmajectAlan J. Khedarri D.D.S., Inc. · 1980
- 3 generations backK991888 MinijectSpartan Ultrasonics, Inc. · 1999
- 2 generations backK040671 Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes…Anthogyr · 2004
- 1 generation backK083796 Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex…Miltex, Inc. · 2009
- This deviceK171254 LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K802483 | Ligmaject | Alan J. Khedarri D.D.S., Inc. | 1980 | — |
| −3 | K991888 | Miniject | Spartan Ultrasonics, Inc. | 1999 | — |
| −2 | K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non… | Anthogyr | 2004 | — |
| −1 | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex… | Miltex, Inc. | 2009 | — |
| 0 (this device) | K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…Summary page 4…Product 510(k) # Miltex, Inc. Miltex Dental Aspirating Syringe K083796 Biodent Co. Denject Disposable Dental Needles Exempt DEVICE DESCRIPTION… | 2009 |
| * | — | Denject Disposable Dental Needles Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 37 years and passes through 5 companies; a new generation was cleared every 8.7 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K083796.
How does its category compare?
All EJI devicesEJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 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.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171254: LeEject 2 Dental Syringe and Needle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171254
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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