510(k) · Cleared

Cleared

Denjector

K081694510(k) TraditionalCleared Sep 12, 200887-day reviewClass II21 CFR 872.6770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Sep 12, 2008 as substantially equivalent to K983105 (Dentsply Midwest, 1999) after an 87-day review. Its family tree reaches back 2 generations to 1996.

Decided: Sep 12, 2008
Review: 87 days
Class: Class II
Product code: EJI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K961648 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961648 The WandSpintech, Inc. · 1996
1 generation backK983105 CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge…Dentsply Midwest · 1999
This deviceK081694 DenjectorDxm Co., Ltd. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961648	The Wand	Spintech, Inc.	1996	—
−1	K983105	CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder…	Dentsply Midwest	1999	—
0 (this device)	K081694	Denjector	Dxm Co., Ltd.	2008	—

FIG. 1 — Lineage of K081694, 1996–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K983105	CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements)… Summary page 1 …on: Class 11,21 CFR 872.6670 5. Predicate Device Information, 003, computer controlled syringe distributed by DENTSPLY Midwest 'rofessional Ltd., K983105 6. Device Description Denjector is a gun type electronic dental aiesthetic cartridge syringe. This device is use~d with inj…	Dentsply Midwest	1999	—

Also cleared against K983105: 1 other device →

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 12 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K983105.

How does its category compare?

All EJI devices

EJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EJI

1in 2017

2007high 3 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EJI

78in 2009

2007high 78 (2009)2026

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

2007high 5 (2012) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	1	—	2
2009	3	78	3
2010	0	—	0
2011	0	—	3
2012	2	—	5
2013	0	—	1
2014	1	—	0
2015	0	—	3
2016	0	—	1
2017	1	—	3
2018	0	—	1
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	1
2026	0	—	—

What is it indicated for?

Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081694 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081694: Denjector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081694

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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