BEUDAMED
    Product Code: EFC FDA class 1 21 CFR 872.6100

    Warmer, Anesthetic Tube

    Dental

    The Anesthetic Tube Warmer is a dental device used to gently warm cartridges of local anesthetic to body temperature before injection, which can reduce the discomfort associated with the administration of cold anesthetic solutions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFC and the applicable regulation is 21 CFR 872.6100, under the Dental medical specialty.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EFC
    Device Class
    FDA class 1
    Regulation Number
    872.6100
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.