510(k) · Cleared
ClearedSafetywand Disposable Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spintech, Inc. · EJI Syringe, Cartridge
Cleared on Sep 2, 2003 as substantially equivalent to K992819 (Spintech, Inc., 2000) and 1 other predicate after a 301-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Sep 2, 2003
- Review
- 301 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851903 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851903 | Astra Lightweight Stainless Steel Self Aspir/Syrin | Astra Pharmaceutical Products, Inc. | 1985 | — |
| −1 | K962999 | Safety Injection System | Integritech, Inc. | 1997 | — |
| 0 (this device) | K023722 | Safetywand Disposable Handpiece | Spintech, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K992819 | Wand PlusSummary page 1…dTMdisposable handpiece is a safety engineered syringe component designed for use with the CompuDentTMcomputer controlled injection system (K992819). The CompuDent@device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various… | 2000 |
| * | K962999 | Safety Injection SystemSummary page 1…cks. The SafetyWandTMis substantially equivalent to the company’s Wand@ handpiece (K992819) and to the IntegriTech Safety Injection System (K962999). Indications for use: To inject local anesthetic agents subcutaneously or intramuscularly for dental… | 1997 |
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 18 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 3 ancestors has a recall.
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 SafetyWand is intended to inject local anesthetic agents subcutaneously or intramuscularly for dental applications. It is a sterile single use handpiece assembly for use with the Milestone Compudent computer controlled injection system. The SafetyWand incorporates safety engineering sharps protection features to aid in the prevention of needlesticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023722: Safetywand Disposable Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023722
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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