FDA 510(k) Applications for Medical Device Product Code "EJI"
(Syringe, Cartridge)

FDA 510(k) Number Applicant Device Name Decision Date
K171254 Advanced Technology and Capital, Inc. LeEject 2 Dental Syringe and Needle System 11/16/2017
K040671 ANTHOGYR EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES 12/14/2004
K092943 ARNOLD TUBER INDUSTRIES ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE 12/11/2009
K002387 DENTSPLY INTL. COMFORT CONTROL SYRINGE SYSTEM 09/28/2000
K983105 DENTSPLY MIDWEST CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 03/08/1999
K081694 DXM CO., LTD. DENJECTOR 09/12/2008
K972285 GETTIG PHARMACEUTICAL INSTRUMENT CO. GETTIG STYRL-JECT DELIVERY SYSTEM 09/11/1997
K043322 HAGER WORLDWIDE, INC. MIRAMATIC SAFE SYRINGE SYSTEM 07/21/2005
K961457 HEALEX PRODUCTS, INC. SUBLIMINATOR 07/18/1996
K120659 HU-FRIEDY MFG. CO. LLC HU-FRIEDY DENTAL CARTRIDGE SYRINGE 11/06/2012
K142414 INTEGRA LIFESCIENCES CORPORATION Miltex N-Tralig Intraligamentary Syringe 10/30/2014
K962999 INTEGRITECH, INC. SAFETY INJECTION SYSTEM 01/22/1997
K113247 KI WORKS CO., LTD. ANESTHESIA INJECTION TOOL SET 03/27/2012
K022959 MDC RESEARCH LTD. SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 02/05/2003
K082249 MEIBACH TECH LTDA MORPHEUS 12/31/2009
K061904 MILESTONE SCIENTIFIC, INC. COMPUDENT STA 08/08/2006
K083796 MILTEX, INC. MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT 03/09/2009
K960270 PROTECS SYRINGES INTERNATIONAL CORP. DENTALOGIC 03/15/1996
K002168 RONVIG INSTRUMENTS, LTD. ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE 10/13/2000
K991888 SPARTAN ULTRASONICS, INC. MINIJECT 08/25/1999
K023722 SPINTECH, INC. SAFETYWAND DISPOSABLE HANDPIECE 09/02/2003
K961648 SPINTECH, INC. THE WAND 07/05/1996
K992819 SPINTECH, INC. WAND PLUS 05/11/2000


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact