Product code EJI
- Device name
- Syringe, Cartridge
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.6770
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017-11-16 |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | 2014-10-30 |
| K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg. Co., LLC | 2012-11-06 |
| K113247 | ANESTHESIA INJECTION TOOL SET | Ki Works Co., Ltd. | 2012-03-27 |
| K082249 | MORPHEUS | Meibach Tech Ltda | 2009-12-31 |
| K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | Arnold Tuber Industries | 2009-12-11 |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | 2009-03-09 |
| K081694 | DENJECTOR | Dxm Co., Ltd. | 2008-09-12 |
| K061904 | COMPUDENT STA | Milestone Scientific, Inc. | 2006-08-08 |
| K043322 | MIRAMATIC SAFE SYRINGE SYSTEM | Hager Worldwide, Inc. | 2005-07-21 |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | Anthogyr | 2004-12-14 |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | 2003-09-02 |
| K022959 | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 | MDC Research , Ltd. | 2003-02-05 |
| K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | 2000-10-13 |
| K002387 | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | 2000-09-28 |
| K992819 | WAND PLUS | Spintech, Inc. | 2000-05-11 |
| K991888 | MINIJECT | Spartan Ultrasonics, Inc. | 1999-08-25 |
| K983105 | CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 | Dentsply Midwest | 1999-03-08 |
| K972285 | GETTIG STYRL-JECT DELIVERY SYSTEM | Gettig Pharmaceutical Instrument Co. | 1997-09-11 |
| K962999 | SAFETY INJECTION SYSTEM | Integritech, Inc. | 1997-01-22 |
| K961457 | SUBLIMINATOR | Healex Products, Inc. | 1996-07-18 |
| K961648 | THE WAND | Spintech, Inc. | 1996-07-05 |
| K960270 | DENTALOGIC | Protecs Syringes International Corp. | 1996-03-15 |
| K945843 | SAFETY PLUS | Arent Fox | 1995-07-11 |
| K950309 | EAGLE | Aalba Dent, Inc. | 1995-02-16 |
| K941915 | ORAL STEEL CARTRIDGE SYRINGE | Robert W. Bauer & Assoc., Inc. | 1995-01-26 |
| K943370 | IMPULSE SEALER PRODUCT LINE | Ultradent Products, Inc. | 1994-10-21 |
| K922683 | PRESTYL JET INJECTOR | Bma Technologies S.A. | 1994-04-11 |
| K926121 | BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI | Dentmed , Ltd. | 1994-02-03 |
| K913769 | SYREX SYRINGE | Special Machinery Co. | 1992-01-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800075614414 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-22 |
| 08800075614360 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-22 |
| 10381780169178 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-26 |
| 10381780174790 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780174783 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-16 |
| 10381780145554 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145400 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145417 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145424 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145646 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145639 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145622 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145615 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145608 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145592 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145585 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145578 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145561 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145431 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145547 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145530 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145523 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145516 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145509 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145493 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145486 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145479 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145462 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145455 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780145448 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |