BEUDAMED
    Product Code: EIL FDA class 1 21 CFR 872.4565

    Gauge, Depth, Instrument, Dental

    Dental

    The Dental Depth Gauge Instrument is a calibrated measuring device used to assess the depth of periodontal pockets, prepared cavities, or implant osteotomy sites, aiding clinical decision-making and ensuring accurate preparation dimensions. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIL, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    8
    FEI Numbers
    139
    Registration Numbers
    139
    Unique Applicants
    7
    Years Active
    9

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    Basic Information

    Product Code
    EIL
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K911643 ABIODENT PERIOTEMP(R) SYSTEM
    K890493 FLORIDA PROBE PERIODONTAL PROBE
    K885075 ABIOMED PERIOTEMP(TM) PROBE
    K884813 MODEL 200A ELECTRONIC FORCE-SENSING PROBE
    K880209 PERIODONTAL PROBE - AUTOPROBE
    K872098 CREMEEN ALVEOLAR BONE CALIPER
    K872215 PERIO-TEST
    K822793 PIO ROOT CANAL INDICATOR

    FEI Numbers

    This FDA classification entry is associated with 139 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 139 registration numbers. Click on an entry to view related FDA registrations.