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 |