510(k) · Cleared
ClearedMiltex N-Tralig Intraligamentary Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · EJI Syringe, Cartridge
Cleared on Oct 30, 2014 as substantially equivalent to K823536 (Miltex Instrument Co., 1982) after a 63-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Oct 30, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K823536 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK823536 IntraligMiltex Instrument Co. · 1982
- This deviceK142414 Miltex N-Tralig Intraligamentary SyringeIntegra LifeSciences Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823536 | Intralig | Miltex Instrument Co. | 1982 | — |
| 0 (this device) | K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | 2014 | — |
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 |
|---|---|---|---|
| * | K823536 | IntraligSummary page 4…Class II Product Code: EJI CFR Classification: 21 CFR 872.6770 Predicate Device: Intralig Intraligamentary Syringe (K823536) This predicate device has not been subject to a design-related recall. Device Description: The… | 1982 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K823536.
How does its category compare?
All EJI devicesEJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142414: Miltex N-Tralig Intraligamentary Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142414
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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