Dental Device Guide
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Miscellaneous devices · 21 CFR 872 Subpart G

Cartridge Syringe

FDA device type “Syringe, Cartridge”.

FDA codeEJIClass221 CFR872.6770Pathway510(k) exemptCategoryDental needles & syringes
Companies listing it
7350 makers
Brands and models
107
510(k) clearances
450 in five years
FDA name
Syringe, Cartridge
1980: 21981: 11982: 21983: 21984: 31985: 11988: 11990: 31992: 11994: 31995: 31996: 31997: 21999: 22000: 32003: 22004: 12005: 12006: 12008: 12009: 32012: 22014: 12017: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EJI

73 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentis Co., Ltd.South KoreaMakerDENOPS372026
Guilin Woodpecker Medical Instrument Co., Ltd.ChinaMakerDental Anesthesia Device (Model: Super Pen, Star Pen)122025
Foshan COXO Medical Instrument Co., Ltd.ChinaMakerDental Anesthesia Booster; GENI, GENI Pro, GENI Pro+62025
Young Innovations IncUnited StatesMakerSYRINGE, CARTRIDGE- Astek232025
Dental Hi TecFranceMakerQuickSleeper5 · Soan SleeperOne512025
Guilin AestheDent Medical Instruments Co., LtdChinaMakerDental Anesthesia Injector; Anesthesia Pen X, Anesthesia Pen Mini12025
SeptodontFranceMaker—172021
Hu-Friedy Mfg Co., LLCUnited StatesMakerCartridge Syringe · Hu-Friedy Mfg Co.,LLC82012
Integra LifeSciences CorporationUnited StatesMakerIntegra · Jarit · Miltex22014
Arnold Tuber IndustriesUnited StatesMakerSyringe12009
Ronvig Dental Mfg. A/SDenmarkMakerASPIJECT · CALAJECT12006
Milestone Scientific, Inc.United StatesMakerCompuDent STA Handpiece · CompuDent STA System · CompuFlo Computer Controlled CathCheck Kit · CompuFlo Computer Controlled Epidural Disposable Kit · +512006
Osung Mnd Co LtdSouth KoreaMakerGMIJ43 · GMIJ48 · SAA1 · SAB1 · +7——
Densol International (Private) LimitedPakistanMakerAspirating Dental Syringe 1.8ml Side Loading Flat Push Rod · Aspirating Dental Syringe 1.8ml Side Loading Harpoon · Aspirating Dental Syringe 1.8ml Side Loading Harpoon without Finger Rest · Aspirating Dental Syringe 1.8ml Side Loading Screw Type · +6——
Signor Seven InternationalPakistanMakerAndrew-Pychon Aspirator SKU 11-902 · Aspirating Syringe SKU 16-2801 · Aspirating Syringes - Cook Waite SKU 16-2803 · Aspirating Syringes Cook-Waite Type SKU 16-2809-A · +5——
B. Ali ImpexPakistanMakerBALI · Carpule——
Dental StudioSouth KoreaMakerSmart Flow Precision Syringe——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerDental Cartridge, Syringe——
B&H Surgical InstrumentPakistanMakerDental Anesthetic Syringe Self-Aspirating - 1.8 CC——
Medcave Private LimitedPakistanMakerSyringe Cartridge——
Accompany SurgicalPakistanMakerASPIRATING SYRINGE——
Lacigrus InternationalPakistanMakerSyringe, cartridge——
Beyes Dental IncCanadaMakerBeyes Dental Anesthesia Device, H1; H2——
Confident InstrumentsPakistanMakerArtman Instruments——
Denta Craft InstrumentsPakistanMakerASPIRATING SYRINGE——
SurgicraftsPakistanMakerEJI / Syringe, cartridge——
Silver Plus Corp.PakistanMakerSyringe, cartridge——
Lohar Medical CompanyPakistanMakerEJI / Syringe, cartridge——
Acme Commercial Ways Ltd.PakistanMakerSyringe, cartridge——
Medesy SrlItalyMakersyringe, cartridge——
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomaPolandMakerCartridge Syringe CHIRMED——
Emerald InstrumentsPakistanMakerSyringe, cartridge——
Laparomed Private LimitedIndiaMakerDENTAL SYRINGES CARTRIDGES——
Tontarra Medizintechnik GmbHGermanyMaker———
INKA Surgical InstrumentsAustraliaMakerN/A——
Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda.BrazilMakerINDUSBELLO——
Medihub Co., Ltd.South KoreaMakerI-JECT B · i-JECT BTS injector · I-JECT MD · i-JECT ST——
J&J InstrumentsUnited StatesMaker———
HEXA DentalUnited StatesMakerHEXA——
medmix Switzerland AGSwitzerlandMakerSyringe, cartridge——
Tricor SystemsUnited StatesMakerCompuDent · CompuDent STA · CompuMed · WAND · +1——
STS CorporationUnited StatesMakerSyringe, Cartridge, Dental - AMTC-K - EJI 2——
DTR Medical LtdUnited KingdomMakerDental Syringes——
Rumex International Co.United StatesMakerRUMEX OPHTHALMIC INSTRUMENTS——
SoficFranceMaker———
Bailey Instruments LtdUnited KingdomMaker———
Goldstar Medical InstrumentsPakistanMaker———
Jaffrose InternationalPakistanMaker———
Nextcon InternationalPakistanMaker———
Wise InstrumentsPakistanMaker———
Aseptico, Inc.United StatesContract manufacturerCAL-2118 Calaject172015
Summit Medical, LLCUnited StatesListerDental Syringe12017
Sotera Health LLCUnited StatesContract manufacturer———
One DashcorpUnited StatesRepacker / relabelerValdent USA——
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributordental irrigation syringe · Dental Syringes · Disposable Dental Syringes · Luer Lock Syringe · +1——
Jmu Dental, Inc.United StatesRepacker / relabelerDental Aspirating Syringe——
Patterson Companies, Inc.United StatesForeign exporterPatterson Aspirating Syringe——
Nordent MFG., Inc.United StatesContract manufacturerSyringe, Cartridge——
PDT Inc.United StatesContract manufacturer———
Wise Linkers LLCUnited StatesRepacker / relabelerArtman Instruments——
IDOC Dental LabUnited StatesContract manufacturerI-JECT; i-JECT BuilT in System——
ArtCraft Dental, Inc.United StatesRepacker / relabelerPDL Gun——
battechUnited StatesRepacker / relabelerdental dispensing gun——
Sanicure BVNetherlandsForeign exporter———
Andersen Caledonia LtdUnited KingdomContract sterilizerSyringe, cartridge——
Karl SchumacherUnited StatesRepacker / relabelerKarl Schumacher Aspirating Syringe——
SeptodontUnited StatesManufacturerAspiject Self-Asperating Syringe——
Avalign TechnologiesUnited StatesContract manufacturer———
Dental Promotion et InnovationBelgiumPrivate-label distributor———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Premier Online Exodontia Courses, Inc.CanadaForeign exporter———
Wise Instruments IncUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
16 Nov 2017K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc.
30 Oct 2014K142414Miltex N-Tralig Intraligamentary SyringeIntegra LifeSciences Corporation
6 Nov 2012K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEHu-Friedy Mfg Co., LLC
27 Mar 2012K113247ANESTHESIA INJECTION TOOL SETKi Works Co., Ltd.
31 Dec 2009K082249MORPHEUSMeibach Tech Ltda
11 Dec 2009K092943ASPIRATING SYRINGE, NON-ASPIRATING SYRINGEArnold Tuber Industries
9 Mar 2009K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTMiltex, Inc.
12 Sep 2008K081694DENJECTORDxm Co., Ltd.
8 Aug 2006K061904COMPUDENT STAMilestone Scientific, Inc.
21 Jul 2005K043322MIRAMATIC SAFE SYRINGE SYSTEMHager Worldwide, Inc.
14 Dec 2004K040671EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGESInstitut Straumann AG
2 Sep 2003K023722SAFETYWAND DISPOSABLE HANDPIECESpintech, Inc.
5 Feb 2003K022959SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1MDC Research , Ltd.
13 Oct 2000K002168ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGERonvig Instruments, Ltd.
28 Sep 2000K002387COMFORT CONTROL SYRINGE SYSTEMDentsply Intl., Inc.
11 May 2000K992819WAND PLUSSpintech, Inc.
25 Aug 1999K991888MINIJECTSpartan Ultrasonics, Inc.
8 Mar 1999K983105CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01Dentsply Midwest
11 Sep 1997K972285GETTIG STYRL-JECT DELIVERY SYSTEMGettig Pharmaceutical Instrument Co.
22 Jan 1997K962999SAFETY INJECTION SYSTEMIntegritech, Inc.
18 Jul 1996K961457SUBLIMINATORHealex Products, Inc.
5 Jul 1996K961648THE WANDSpintech, Inc.
15 Mar 1996K960270DENTALOGICProtecs Syringes International Corp.
11 Jul 1995K945843SAFETY PLUSArent Fox
16 Feb 1995K950309EAGLEAalba Dent, Inc.
26 Jan 1995K941915ORAL STEEL CARTRIDGE SYRINGERobert W. Bauer & Assoc., Inc.
21 Oct 1994K943370IMPULSE SEALER PRODUCT LINEUltradent Products, Inc.
11 Apr 1994K922683PRESTYL JET INJECTORBma Technologies S.A.
3 Feb 1994K926121BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTIDentmed , Ltd.
23 Jan 1992K913769SYREX SYRINGESpecial Machinery Co.
21 Dec 1990K904527KAPPERSenair-Mot
2 Nov 1990K904278HOLDER, DENTAL BUR, ALUMINUMMaverick Surgical, Inc.
19 Sep 1990K903007MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVERHabley Medical Technology Corp.
18 Apr 1988K880621CAPCADDYCapcad, Inc.
2 Jul 1985K851903ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRINAstra Pharmaceutical Products, Inc.
27 Sep 1984K843314MPL HYPO BRAND BREECH LOAD ASPIR SYRINGESmith & Nephew, Mpl Division
16 Jul 1984K842006CITOJECT CARTRIDGE SYRINGEMiles Laboratories, Inc.
13 Jan 1984K833426DOCTOR VELLETTE'S INJECTORDeproco, Inc.
24 Mar 1983K830524HENKE JECT PRESSURE SYRINGESmith & Nephew, Mpl Division
26 Jan 1983K830042E-Z JECTORInnovators, Inc.
28 Dec 1982K823536INTRALIGMiltex Instrument Co.
20 Jul 1982K821782BEACH ANESTHETIC SYRINGE CARTR. TYPEPacific Dental Corp.
8 Sep 1981K811831MULTI-PURPOSE DENTAL SYRINGECentrix, Inc.
12 Nov 1980K802483LIGMAJECTAlan J. Khedarri D.D.S., Inc.
1 Feb 1980K792541MONOJECT PLASTIC DENTAL INJ. SYRINGESherwood Medical Co.

Official records: FDA product classification for EJI · 21 CFR 872.6770.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026