BEUDAMED
    Product Code: EGQ FDA class 2 21 CFR 872.4465

    Injector, Jet, Gas-Powered

    Dental

    The Jet Injector, Gas-Powered is a needleless dental injection device that uses compressed gas to propel local anesthetic through the skin or mucosal tissue at high velocity, providing an alternative to conventional syringe delivery. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and adherence to applicable special controls. The product code is EGQ, regulated under 21 CFR 872.4465 in the Dental (DE) specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    EGQ
    Device Class
    FDA class 2
    Regulation Number
    872.4465
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K901348 WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS