BEUDAMED
    Product Code: EAS FDA class 1 21 CFR 872.1730

    Gel, Electrode, For Pulp Tester

    Dental

    The Electrode Gel for Pulp Tester is a dental device consisting of a conductive medium applied between the tip of an electric pulp tester and the tooth surface to facilitate the transmission of electrical stimulus used to assess tooth pulp vitality. 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 EAS and the applicable regulation is 21 CFR 872.1730, under the Dental medical specialty.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    EAS
    Device Class
    FDA class 1
    Regulation Number
    872.1730
    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 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.