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EJI — Syringe, Cartridge Class II

FDA Device Classification

FDA product code EJI covers "Syringe, Cartridge", a Class II medical device regulated under 21 CFR 872.6770. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EJI
Device Class
Class II
Regulation Number
872.6770
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K171254advanced technology and capitalLeEject 2 Dental Syringe and Needle SystemNovember 16, 2017
K142414integra lifesciences corporationMiltex N-Tralig Intraligamentary SyringeOctober 30, 2014
K120659hu-friedy mfg. coHU-FRIEDY DENTAL CARTRIDGE SYRINGENovember 6, 2012
K113247ki works coANESTHESIA INJECTION TOOL SETMarch 27, 2012
K082249meibach tech ltdaMORPHEUSDecember 31, 2009
K092943arnold tuber industriesASPIRATING SYRINGE, NON-ASPIRATING SYRINGEDecember 11, 2009
K083796miltexMILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATMarch 9, 2009
K081694dxm coDENJECTORSeptember 12, 2008
K061904milestone scientificCOMPUDENT STAAugust 8, 2006
K043322hager worldwideMIRAMATIC SAFE SYRINGE SYSTEMJuly 21, 2005
K040671anthogyrEROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATINGDecember 14, 2004
K023722spintechSAFETYWAND DISPOSABLE HANDPIECESeptember 2, 2003
K022959mdc researchSAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1February 5, 2003
K002168ronvig instrumentsASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGEOctober 13, 2000
K002387dentsply intlCOMFORT CONTROL SYRINGE SYSTEMSeptember 28, 2000
K992819spintechWAND PLUSMay 11, 2000
K991888spartan ultrasonicsMINIJECTAugust 25, 1999
K983105dentsply midwestCCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMarch 8, 1999
K972285gettig pharmaceutical instrumentGETTIG STYRL-JECT DELIVERY SYSTEMSeptember 11, 1997
K962999integritechSAFETY INJECTION SYSTEMJanuary 22, 1997

FDA data resources