BEUDAMED
    Product Code: EGM FDA class 2 21 CFR 872.4475

    Injector, Jet, Mechanical-Powered

    Dental

    The Jet Injector, Mechanical-Powered is a dental device that delivers local anesthetic agents into tissue using a high-pressure jet mechanism driven by mechanical force, eliminating the need for a traditional needle. It is classified as FDA Class 2 (moderate risk), meaning manufacturers must demonstrate substantial equivalence through the 510(k) premarket notification process and comply with applicable special controls. The product code is EGM and it falls under 21 CFR 872.4475 in the Dental (DE) specialty. This device is eligible for third-party review under the FDA's Accredited Persons program.

    View on FDA
    510(k)s
    11
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    11
    Years Active
    46

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    Basic Information

    Product Code
    EGM
    Device Class
    FDA class 2
    Regulation Number
    872.4475
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K243427 QuickSleeper 5
    K083811 W&H HANDPIECE ANESTO, MODEL: RA-5
    K964802 CYBERJET LOCAL ANESTHESIA SYSTEM
    K962017 HYPODERMIC JET INJECTION APPARATUS
    K904279 PAROJECT ANESTHETIC SYRINGE
    K864294 HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
    K864732 GRADTECH SYRINGE SYSTEM
    K864861 INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM
    K834361 JSB JET SYRINGE
    K821273 MAYO SCISSOR STRAIGHT 6 3/4
    K790193 MIZZY SYRIJET MARK IV

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.