BEUDAMED
    Product Code: OIV FDA class 2 21 CFR 872.3070

    Dental Amalgam

    Dental

    Dental Amalgam is a metallic restorative material composed of an alloy of silver, tin, copper, and zinc mixed with liquid elemental mercury, used for the direct filling of carious lesions (cavities) or structural defects in teeth. Classified as FDA Class 2 under regulation 21 CFR 872.3070 within the Dental medical specialty, it requires a 510(k) premarket notification and is eligible for third-party review. The product code is OIV. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    3
    Years Active
    15

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    Basic Information

    Product Code
    OIV
    Device Class
    FDA class 2
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K223182 Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
    K140125 NEW STETIC DENTAL AMALGAM ALLOY
    K081273 ULTRACAPS S

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.