EJI · Syringe, Cartridge
Dental · 21 CFR 872.6770 · Class 2
Overview
| Product Code | EJI |
|---|---|
| Device Name | Syringe, Cartridge |
| Regulation | 21 CFR 872.6770 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | Nov 16, 2017 | SESE |
| K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | Oct 30, 2014 | SESE |
| K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg. Co., LLC | Nov 6, 2012 | SESE |
| K113247 | ANESTHESIA INJECTION TOOL SET | Ki Works Co., Ltd. | Mar 27, 2012 | SESE |
| K082249 | MORPHEUS | Meibach Tech Ltda | Dec 31, 2009 | SESE |
| K092943 | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | Arnold Tuber Industries | Dec 11, 2009 | SESE |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | Mar 9, 2009 | SESE |
| K081694 | DENJECTOR | Dxm Co., Ltd. | Sep 12, 2008 | SESE |
| K061904 | COMPUDENT STA | Milestone Scientific, Inc. | Aug 8, 2006 | SESE |
| K043322 | MIRAMATIC SAFE SYRINGE SYSTEM | Hager Worldwide, Inc. | Jul 21, 2005 | SESE |
| K040671 | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | Anthogyr | Dec 14, 2004 | SESE |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | Sep 2, 2003 | SESE |
| K022959 | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 | MDC Research , Ltd. | Feb 5, 2003 | SESE |
| K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | Oct 13, 2000 | SESE |
| K002387 | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | Sep 28, 2000 | SESE |
| K992819 | WAND PLUS | Spintech, Inc. | May 11, 2000 | SESE |
| K991888 | MINIJECT | Spartan Ultrasonics, Inc. | Aug 25, 1999 | SESE |
| K983105 | CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 | Dentsply Midwest | Mar 8, 1999 | SESE |
| K972285 | GETTIG STYRL-JECT DELIVERY SYSTEM | Gettig Pharmaceutical Instrument Co. | Sep 11, 1997 | SESE |
| K962999 | SAFETY INJECTION SYSTEM | Integritech, Inc. | Jan 22, 1997 | SESE |
Top Applicants
- Spintech, Inc. — 3 clearances
- Smith & Nephew, Mpl Division — 2 clearances
- Aalba Dent, Inc. — 1 clearance
- Advanced Technology and Capital, Inc. — 1 clearance
- Alan J. Khedarri D.D.S., Inc. — 1 clearance
