BEUDAMED
    Product Code: POW FDA class 2 21 CFR 872.3770

    Crown And Bridge, Long-Term Temporary, Resin

    Dental

    The Crown And Bridge, Long-Term Temporary, Resin (product code POW) is a Class 2 dental device intended for the fabrication of long-term temporary crowns and bridges, regulated under 872.3770. It requires 510(k) clearance and falls within the dental medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    POW
    Device Class
    FDA class 2
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    For the fabrication of long-term temporary crowns and bridges

    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
    K231591 V-Print c&b temp

    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.