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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: EJI FDA class 2

    Syringe, Cartridge

    Dental

    View full classification →

    The Cartridge Syringe is a dental delivery device designed to accept prefilled anesthetic cartridges and deliver local anesthetic solutions by needle injection, providing a secure, hygienic, and ergonomic means of administering dental anesthesia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EJI, regulated under 21 CFR 872.6770 in the Dental (DE) specialty.

    510(k) Clearances

    45 matches
    K Number
    Device Name
    LeEject 2 Dental Syringe and Needle System
    Miltex N-Tralig Intraligamentary Syringe
    HU-FRIEDY DENTAL CARTRIDGE SYRINGE
    ANESTHESIA INJECTION TOOL SET
    MORPHEUS
    ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
    MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
    DENJECTOR
    COMPUDENT STA
    MIRAMATIC SAFE SYRINGE SYSTEM
    EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
    SAFETYWAND DISPOSABLE HANDPIECE
    SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
    ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
    COMFORT CONTROL SYRINGE SYSTEM
    WAND PLUS
    MINIJECT
    CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01
    GETTIG STYRL-JECT DELIVERY SYSTEM
    SAFETY INJECTION SYSTEM
    SUBLIMINATOR
    THE WAND
    DENTALOGIC
    SAFETY PLUS
    EAGLE
    ORAL STEEL CARTRIDGE SYRINGE
    IMPULSE SEALER PRODUCT LINE
    PRESTYL JET INJECTOR
    BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI
    SYREX SYRINGE
    KAPPER
    HOLDER, DENTAL BUR, ALUMINUM
    MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER
    CAPCADDY
    ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN
    MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE
    CITOJECT CARTRIDGE SYRINGE
    DOCTOR VELLETTE'S INJECTOR
    HENKE JECT PRESSURE SYRINGE
    E-Z JECTOR
    INTRALIG
    BEACH ANESTHETIC SYRINGE CARTR. TYPE
    MULTI-PURPOSE DENTAL SYRINGE
    LIGMAJECT
    MONOJECT PLASTIC DENTAL INJ. SYRINGE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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