Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6770](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6770) → EJI — Syringe, Cartridge # EJI · Syringe, Cartridge _Dental · 21 CFR 872.6770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI ## Overview - **Product Code:** EJI - **Device Name:** Syringe, Cartridge - **Regulation:** [21 CFR 872.6770](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6770) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) ## 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](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K171254.md) | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | Nov 16, 2017 | SESE | | [K142414](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K142414.md) | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | Oct 30, 2014 | SESE | | [K120659](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K120659.md) | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | Hu-Friedy Mfg. Co., LLC | Nov 6, 2012 | SESE | | [K113247](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K113247.md) | ANESTHESIA INJECTION TOOL SET | Ki Works Co., Ltd. | Mar 27, 2012 | SESE | | [K082249](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K082249.md) | MORPHEUS | Meibach Tech Ltda | Dec 31, 2009 | SESE | | [K092943](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K092943.md) | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE | Arnold Tuber Industries | Dec 11, 2009 | SESE | | [K083796](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K083796.md) | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | Mar 9, 2009 | SESE | | [K081694](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K081694.md) | DENJECTOR | Dxm Co., Ltd. | Sep 12, 2008 | SESE | | [K061904](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K061904.md) | COMPUDENT STA | Milestone Scientific, Inc. | Aug 8, 2006 | SESE | | [K043322](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K043322.md) | MIRAMATIC SAFE SYRINGE SYSTEM | Hager Worldwide, Inc. | Jul 21, 2005 | SESE | | [K040671](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K040671.md) | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES | Anthogyr | Dec 14, 2004 | SESE | | [K023722](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K023722.md) | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | Sep 2, 2003 | SESE | | [K022959](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K022959.md) | SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 | MDC Research , Ltd. | Feb 5, 2003 | SESE | | [K002168](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K002168.md) | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | Oct 13, 2000 | SESE | | [K002387](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K002387.md) | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | Sep 28, 2000 | SESE | | [K992819](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K992819.md) | WAND PLUS | Spintech, Inc. | May 11, 2000 | SESE | | [K991888](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K991888.md) | MINIJECT | Spartan Ultrasonics, Inc. | Aug 25, 1999 | SESE | | [K983105](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K983105.md) | CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 | Dentsply Midwest | Mar 8, 1999 | SESE | | [K972285](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K972285.md) | GETTIG STYRL-JECT DELIVERY SYSTEM | Gettig Pharmaceutical Instrument Co. | Sep 11, 1997 | SESE | | [K962999](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI/K962999.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com