BEUDAMED
    Product Code: DZS FDA class 1 21 CFR 872.3110

    Capsule, Dental, Amalgam

    Dental

    The Dental Amalgam Capsule is a pre-proportioned, pre-measured container holding the components of dental amalgam (alloy and mercury) in separate compartments that are mixed by mechanical trituration immediately before use as a restorative filling material. 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 DZS and the applicable regulation is 21 CFR 872.3110, under the Dental medical specialty.

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    510(k)s
    4
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    3
    Years Active
    4

    Basic Information

    Product Code
    DZS
    Device Class
    FDA class 1
    Regulation Number
    872.3110
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K822610 PRECAPSULED DENTAL AMALGAM
    K802967 DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
    K781243 MERCURY DISP. CAPSULE
    K780966 LEE-ALLOY DISPOSABLE CAPSULES

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.