EJI · Class II · 21 CFR 872.6770

FDA Product Code EJI: Syringe, Cartridge

Leading manufacturers include Spintech, Inc., Dentsply Intl. and Integritech, Inc..

45
Total
45
Cleared
138d
Avg days
1980
Since

FDA 510(k) Cleared Syringe, Cartridge Devices (Product Code EJI)

45 devices
1–24 of 45
Cleared Nov 16, 2017
LeEject 2 Dental Syringe and Needle System
K171254
Advanced Technology and Capital, Inc.
Dental · 202d
Cleared Oct 30, 2014
Miltex N-Tralig Intraligamentary Syringe
K142414
Integra LifeSciences Corporation
Dental · 63d
Cleared Nov 06, 2012
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
K120659
Hu-Friedy Mfg. Co., LLC
Dental · 246d
Cleared Mar 27, 2012
ANESTHESIA INJECTION TOOL SET
K113247
Ki Works Co., Ltd.
Dental · 146d
Cleared Mar 09, 2009
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
K083796
Miltex, Inc.
Dental · 77d
Cleared Jul 21, 2005
MIRAMATIC SAFE SYRINGE SYSTEM
K043322
Hager Worldwide, Inc.
Dental · 231d
Cleared Sep 28, 2000
COMFORT CONTROL SYRINGE SYSTEM
K002387
Dentsply Intl.
Dental · 55d
Cleared May 11, 2000
WAND PLUS
K992819
Spintech, Inc.
Dental · 265d
Cleared Aug 25, 1999
MINIJECT
K991888
Spartan Ultrasonics, Inc.
Dental · 84d
Cleared Mar 08, 1999
CCS
K983105
Dentsply Midwest
Dental · 185d
Cleared Sep 11, 1997
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285
Gettig Pharmaceutical Instrument Co.
Dental · 84d
Cleared Jan 22, 1997
SAFETY INJECTION SYSTEM
K962999
Integritech, Inc.
Dental · 173d
Cleared Jul 18, 1996
SUBLIMINATOR
K961457
Healex Products, Inc.
Dental · 93d
Cleared Jul 05, 1996
THE WAND
K961648
Spintech, Inc.
Dental · 67d
Cleared Mar 15, 1996
DENTALOGIC
K960270
Protecs Syringes International Corp.
Dental · 57d
Cleared Feb 16, 1995
EAGLE
K950309
Aalba Dent, Inc.
Dental · 22d
Cleared Oct 21, 1994
IMPULSE SEALER PRODUCT LINE
K943370
Ultradent Products, Inc.
Dental · 100d
Cleared Jul 16, 1984
CITOJECT CARTRIDGE SYRINGE
K842006
Miles Laboratories, Inc.
Dental · 60d
Cleared Jul 20, 1982
BEACH ANESTHETIC SYRINGE CARTR. TYPE
K821782
Pacific Dental Corp.
Dental · 33d
Cleared Sep 08, 1981
MULTI-PURPOSE DENTAL SYRINGE
K811831
Centrix, Inc.
Dental · 71d
Cleared Feb 01, 1980
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541
Sherwood Medical Co.
Dental · 53d

About Product Code EJI - Regulatory Context