FDA Product Code
FDA Product Code EJI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6770
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017-11-16 | Traditional | PDF ↗ |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | 2014-10-30 | Special | PDF ↗ |
| K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg. Co., LLC | 2012-11-06 | Traditional | PDF ↗ |
| K113247 | ANESTHESIA INJECTION TOOL SET | Ki Works Co., Ltd. | 2012-03-27 | Traditional | PDF ↗ |
| K082249 | MORPHEUS | Meibach Tech Ltda | 2009-12-31 | Abbreviated | PDF ↗ |
| K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | Arnold Tuber Industries | 2009-12-11 | Traditional | PDF ↗ |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | 2009-03-09 | Traditional | PDF ↗ |
| K081694 | DENJECTOR | Dxm Co., Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K061904 | COMPUDENT STA | Milestone Scientific, Inc. | 2006-08-08 | Traditional | PDF ↗ |
| K043322 | MIRAMATIC SAFE SYRINGE SYSTEM | Hager Worldwide, Inc. | 2005-07-21 | Traditional | PDF ↗ |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | Anthogyr | 2004-12-14 | Traditional | PDF ↗ |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | 2003-09-02 | Traditional | PDF ↗ |
| K022959 | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 | MDC Research , Ltd. | 2003-02-05 | Traditional | PDF ↗ |
| K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | 2000-10-13 | Abbreviated | PDF ↗ |
| K002387 | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | 2000-09-28 | Traditional | PDF ↗ |
| K992819 | WAND PLUS | Spintech, Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K991888 | MINIJECT | Spartan Ultrasonics, Inc. | 1999-08-25 | Traditional | PDF ↗ |
| K983105 | CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 | Dentsply Midwest | 1999-03-08 | Traditional | PDF ↗ |
| K972285 | GETTIG STYRL-JECT DELIVERY SYSTEM | Gettig Pharmaceutical Instrument Co. | 1997-09-11 | Traditional | PDF ↗ |
| K962999 | SAFETY INJECTION SYSTEM | Integritech, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K961457 | SUBLIMINATOR | Healex Products, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K961648 | THE WAND | Spintech, Inc. | 1996-07-05 | Traditional | PDF ↗ |
| K960270 | DENTALOGIC | Protecs Syringes International Corp. | 1996-03-15 | Traditional | PDF ↗ |
| K945843 | SAFETY PLUS | Arent Fox | 1995-07-11 | Traditional | PDF ↗ |
| K950309 | EAGLE | Aalba Dent, Inc. | 1995-02-16 | Traditional | PDF ↗ |
| K941915 | ORAL STEEL CARTRIDGE SYRINGE | Robert W. Bauer & Assoc., Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K943370 | IMPULSE SEALER PRODUCT LINE | Ultradent Products, Inc. | 1994-10-21 | Traditional | PDF ↗ |
| K922683 | PRESTYL JET INJECTOR | Bma Technologies S.A. | 1994-04-11 | Traditional | PDF ↗ |
| K926121 | BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI | Dentmed , Ltd. | 1994-02-03 | Traditional | PDF ↗ |
| K913769 | SYREX SYRINGE | Special Machinery Co. | 1992-01-23 | Traditional | PDF ↗ |
| K904527 | KAPPER | Senair-Mot | 1990-12-21 | Traditional | PDF ↗ |
| K904278 | HOLDER, DENTAL BUR, ALUMINUM | Maverick Surgical, Inc. | 1990-11-02 | Traditional | PDF ↗ |
| K903007 | MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER | Habley Medical Technology Corp. | 1990-09-19 | Traditional | PDF ↗ |
| K880621 | CAPCADDY | Capcad, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K851903 | ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN | Astra Pharmaceutical Products, Inc. | 1985-07-02 | Traditional | PDF ↗ |
| K843314 | MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE | Smith & Nephew, Mpl Division | 1984-09-27 | Traditional | PDF ↗ |
| K842006 | CITOJECT CARTRIDGE SYRINGE | Miles Laboratories, Inc. | 1984-07-16 | Traditional | PDF ↗ |
| K833426 | DOCTOR VELLETTE'S INJECTOR | Deproco, Inc. | 1984-01-13 | Traditional | PDF ↗ |
| K830524 | HENKE JECT PRESSURE SYRINGE | Smith & Nephew, Mpl Division | 1983-03-24 | Traditional | PDF ↗ |
| K830042 | E-Z JECTOR | Innovators, Inc. | 1983-01-26 | Traditional | PDF ↗ |
| K823536 | INTRALIG | Miltex Instrument Co. | 1982-12-28 | Traditional | PDF ↗ |
| K821782 | BEACH ANESTHETIC SYRINGE CARTR. TYPE | Pacific Dental Corp. | 1982-07-20 | Traditional | PDF ↗ |
| K811831 | MULTI-PURPOSE DENTAL SYRINGE | Centrix, Inc. | 1981-09-08 | Traditional | PDF ↗ |
| K802483 | LIGMAJECT | Alan J. Khedarri D.D.S., Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K792541 | MONOJECT PLASTIC DENTAL INJ. SYRINGE | Sherwood Medical Co. | 1980-02-01 | Traditional | PDF ↗ |
Product code EJI · Class II · Dental. Data: openFDA.