510(k) · Cleared

Cleared

CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements), Model # CCS-100-01

K983105510(k) TraditionalCleared Mar 8, 1999185-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

Dentsply Midwest · EJI Syringe, Cartridge

Cleared on Mar 8, 1999 as substantially equivalent to K961648 (Spintech, Inc., 1996) after a 185-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.

Decided: Mar 8, 1999
Review: 185 days
Class: Class II
Product code: EJI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K961648 (1996). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK961648 The WandSpintech, Inc. · 1996
This deviceK983105 CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge…Dentsply Midwest · 1999
Descendant · cites it directly · 0 of its ownK081694 DenjectorDxm Co., Ltd. · 2008
Descendant · cites it directly · 0 of its ownK992404 The WandSpintech, Inc. · 2000

Most influential descendants

Showing 2 of 2 · See all

K081694DenjectorDxm Co., Ltd. · 2008 · cites it directly0descendants
K992404The WandSpintech, Inc. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961648	The Wand	Spintech, Inc.	1996	—
0 (this device)	K983105	CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder…	Dentsply Midwest	1999	—
+1	K081694	Denjector	Dxm Co., Ltd.	2008	—
+1	K992404	The Wand	Spintech, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2008	1	0

FIG. 1 — Lineage of K983105, 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
*	K961648	The Wand Summary page 1 …62 Steve Long, President August 31, 1998 CCS Computer Controlled Syringe (Model CCS-100) CCS Cartridge Holder (Model CCS-100-01) Class II. 21 CFR 872.6770 The Wand (K961648) The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commerci…	Spintech, Inc.	1996	—

Also cleared against K961648: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081694	Denjector	Dxm Co., Ltd.	2008	0
K992404	The Wand	Spintech, Inc.	2000	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, K081694 (Dxm Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K961648.

How does its category compare?

All EJI devices

EJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Computer Controlled Syringe is an electronic programmable device indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983105 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983105: CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements), Model # CCS-100-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983105

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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