Product Code: EJI FDA class 2 21 CFR 872.6770

Syringe, Cartridge

Dental

The Cartridge Syringe is a dental delivery device designed to accept prefilled anesthetic cartridges and deliver local anesthetic solutions by needle injection, providing a secure, hygienic, and ergonomic means of administering dental anesthesia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EJI, regulated under 21 CFR 872.6770 in the Dental (DE) specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EJI
Device Class: FDA class 2
Regulation Number: 872.6770
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171254	LeEject 2 Dental Syringe and Needle System	Nov 16, 2017	Substantially Equivalent	Advanced Technology and Capital, Inc.
K142414	Miltex N-Tralig Intraligamentary Syringe	Oct 30, 2014	Substantially Equivalent	Integra LifeSciences Corporation
K120659	HU-FRIEDY DENTAL CARTRIDGE SYRINGE	Nov 06, 2012	Substantially Equivalent	Hu-Friedy Mfg. Co., LLC
K113247	ANESTHESIA INJECTION TOOL SET	Mar 27, 2012	Substantially Equivalent	Ki Works Co., Ltd.
K082249	MORPHEUS	Dec 31, 2009	Substantially Equivalent	Meibach Tech Ltda
K092943	ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE	Dec 11, 2009	Substantially Equivalent	Arnold Tuber Industries
K083796	MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT	Mar 09, 2009	Substantially Equivalent	Miltex, Inc.
K081694	DENJECTOR	Sep 12, 2008	Substantially Equivalent	Dxm Co., Ltd.
K061904	COMPUDENT STA	Aug 08, 2006	Substantially Equivalent	Milestone Scientific, Inc.
K043322	MIRAMATIC SAFE SYRINGE SYSTEM	Jul 21, 2005	Substantially Equivalent	Hager Worldwide, Inc.
K040671	EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES	Dec 14, 2004	Substantially Equivalent	Anthogyr
K023722	SAFETYWAND DISPOSABLE HANDPIECE	Sep 02, 2003	Substantially Equivalent	Spintech, Inc.
K022959	SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1	Feb 05, 2003	Substantially Equivalent	MDC Research , Ltd.
K002168	ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE	Oct 13, 2000	Substantially Equivalent	Ronvig Instruments, Ltd.
K002387	COMFORT CONTROL SYRINGE SYSTEM	Sep 28, 2000	Substantially Equivalent	Dentsply Intl.
K992819	WAND PLUS	May 11, 2000	Substantially Equivalent	Spintech, Inc.
K991888	MINIJECT	Aug 25, 1999	Substantially Equivalent	Spartan Ultrasonics, Inc.
K983105	CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01	Mar 08, 1999	Substantially Equivalent	Dentsply Midwest
K972285	GETTIG STYRL-JECT DELIVERY SYSTEM	Sep 11, 1997	Substantially Equivalent	Gettig Pharmaceutical Instrument Co.
K962999	SAFETY INJECTION SYSTEM	Jan 22, 1997	Substantially Equivalent	Integritech, Inc.
K961457	SUBLIMINATOR	Jul 18, 1996	Substantially Equivalent	Healex Products, Inc.
K961648	THE WAND	Jul 05, 1996	Substantially Equivalent	Spintech, Inc.
K960270	DENTALOGIC	Mar 15, 1996	Substantially Equivalent	Protecs Syringes International Corp.
K945843	SAFETY PLUS	Jul 11, 1995	Substantially Equivalent	Arent Fox
K950309	EAGLE	Feb 16, 1995	Substantially Equivalent	Aalba Dent, Inc.
K941915	ORAL STEEL CARTRIDGE SYRINGE	Jan 26, 1995	Substantially Equivalent	Robert W. Bauer & Assoc., Inc.
K943370	IMPULSE SEALER PRODUCT LINE	Oct 21, 1994	Substantially Equivalent	Ultradent Products, Inc.
K922683	PRESTYL JET INJECTOR	Apr 11, 1994	Substantially Equivalent	Bma Technologies S.A.
K926121	BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI	Feb 03, 1994	Substantially Equivalent	Dentmed , Ltd.
K913769	SYREX SYRINGE	Jan 23, 1992	Substantially Equivalent	Special Machinery Co.
K904527	KAPPER	Dec 21, 1990	Substantially Equivalent	Senair-Mot
K904278	HOLDER, DENTAL BUR, ALUMINUM	Nov 02, 1990	Substantially Equivalent	Maverick Surgical, Inc.
K903007	MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER	Sep 19, 1990	Substantially Equivalent	Habley Medical Technology Corp.
K880621	CAPCADDY	Apr 18, 1988	Substantially Equivalent	Capcad, Inc.
K851903	ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN	Jul 02, 1985	Substantially Equivalent	Astra Pharmaceutical Products, Inc.
K843314	MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE	Sep 27, 1984	Substantially Equivalent	Smith & Nephew, Mpl Division
K842006	CITOJECT CARTRIDGE SYRINGE	Jul 16, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K833426	DOCTOR VELLETTE'S INJECTOR	Jan 13, 1984	Substantially Equivalent	Deproco, Inc.
K830524	HENKE JECT PRESSURE SYRINGE	Mar 24, 1983	Substantially Equivalent	Smith & Nephew, Mpl Division
K830042	E-Z JECTOR	Jan 26, 1983	Substantially Equivalent	Innovators, Inc.
K823536	INTRALIG	Dec 28, 1982	Substantially Equivalent	Miltex Instrument Co.
K821782	BEACH ANESTHETIC SYRINGE CARTR. TYPE	Jul 20, 1982	Substantially Equivalent	Pacific Dental Corp.
K811831	MULTI-PURPOSE DENTAL SYRINGE	Sep 08, 1981	Substantially Equivalent	Centrix, Inc.
K802483	LIGMAJECT	Nov 12, 1980	Substantially Equivalent	Alan J. Khedarri D.D.S., Inc.
K792541	MONOJECT PLASTIC DENTAL INJ. SYRINGE	Feb 01, 1980	Substantially Equivalent	Sherwood Medical Co.