Atlas FDA

EJI

45 FDA 510(k) clearances · Product code

84 daysmedian time to decision
282 days90th percentile
45clearances measured

FDA profile

Official device name
Syringe, Cartridge
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6770
Medical specialty
Dental
Adverse events (MAUDE)
1999: 1 · 2000: 1 · 2003: 2 · 2008: 2 · 2009: 3 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LeEject 2 Dental Syringe and Needle System (K171254)Advanced Technology and Capital, Inc.2017-11-16
Miltex N-Tralig Intraligamentary Syringe (K142414)Integra LifeSciences Corporation2014-10-30
HU-FRIEDY DENTAL CARTRIDGE SYRINGE (K120659)Hu-Friedy Mfg. Co., LLC2012-11-06
ANESTHESIA INJECTION TOOL SET (K113247)Ki Works Co., Ltd.2012-03-27
MORPHEUS (K082249)Meibach Tech Ltda2009-12-31
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (K092943)Arnold Tuber Industries2009-12-11
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT (K083796)Miltex, Inc.2009-03-09
DENJECTOR (K081694)Dxm Co., Ltd.2008-09-12
COMPUDENT STA (K061904)Milestone Scientific, Inc.2006-08-08
MIRAMATIC SAFE SYRINGE SYSTEM (K043322)Hager Worldwide, Inc.2005-07-21
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES (K040671)Anthogyr2004-12-14
SAFETYWAND DISPOSABLE HANDPIECE (K023722)Spintech, Inc.2003-09-02
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 (K022959)MDC Research , Ltd.2003-02-05
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE (K002168)Ronvig Instruments, Ltd.2000-10-13
COMFORT CONTROL SYRINGE SYSTEM (K002387)Dentsply Intl.2000-09-28
WAND PLUS (K992819)Spintech, Inc.2000-05-11
MINIJECT (K991888)Spartan Ultrasonics, Inc.1999-08-25
CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 (K983105)Dentsply Midwest1999-03-08
GETTIG STYRL-JECT DELIVERY SYSTEM (K972285)Gettig Pharmaceutical Instrument Co.1997-09-11
SAFETY INJECTION SYSTEM (K962999)Integritech, Inc.1997-01-22
SUBLIMINATOR (K961457)Healex Products, Inc.1996-07-18
THE WAND (K961648)Spintech, Inc.1996-07-05
DENTALOGIC (K960270)Protecs Syringes International Corp.1996-03-15
SAFETY PLUS (K945843)Arent Fox1995-07-11
EAGLE (K950309)Aalba Dent, Inc.1995-02-16
ORAL STEEL CARTRIDGE SYRINGE (K941915)Robert W. Bauer & Assoc., Inc.1995-01-26
IMPULSE SEALER PRODUCT LINE (K943370)Ultradent Products, Inc.1994-10-21
PRESTYL JET INJECTOR (K922683)Bma Technologies S.A.1994-04-11
BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI (K926121)Dentmed , Ltd.1994-02-03
SYREX SYRINGE (K913769)Special Machinery Co.1992-01-23
KAPPER (K904527)Senair-Mot1990-12-21
HOLDER, DENTAL BUR, ALUMINUM (K904278)Maverick Surgical, Inc.1990-11-02
MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER (K903007)Habley Medical Technology Corp.1990-09-19
CAPCADDY (K880621)Capcad, Inc.1988-04-18
ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN (K851903)Astra Pharmaceutical Products, Inc.1985-07-02
MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE (K843314)Smith & Nephew, Mpl Division1984-09-27
CITOJECT CARTRIDGE SYRINGE (K842006)Miles Laboratories, Inc.1984-07-16
DOCTOR VELLETTE'S INJECTOR (K833426)Deproco, Inc.1984-01-13
HENKE JECT PRESSURE SYRINGE (K830524)Smith & Nephew, Mpl Division1983-03-24
E-Z JECTOR (K830042)Innovators, Inc.1983-01-26
INTRALIG (K823536)Miltex Instrument Co.1982-12-28
BEACH ANESTHETIC SYRINGE CARTR. TYPE (K821782)Pacific Dental Corp.1982-07-20
MULTI-PURPOSE DENTAL SYRINGE (K811831)Centrix, Inc.1981-09-08
LIGMAJECT (K802483)Alan J. Khedarri D.D.S., Inc.1980-11-12
MONOJECT PLASTIC DENTAL INJ. SYRINGE (K792541)Sherwood Medical Co.1980-02-01

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