BEUDAMED
    Product Code: DZG FDA class 3

    Suture, Dental

    Unknown

    The Dental Suture is a device used by dental and oral surgeons to close and approximate soft tissue wounds in the oral cavity following surgical procedures such as tooth extractions, periodontal surgery, or implant placement. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness before marketing; no regulation number is currently assigned. The product code is DZG, and this device is an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    DZG
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    2

    Device Characteristics

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