BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Dental LT Comfort Resin

    K Number: K232087 · Decision Feb 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    3
    Review Days
    218

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    Basic Information

    Device Name
    Dental LT Comfort Resin
    K Number
    K232087
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Formlabs Ohio, Inc.
    Date Received
    July 13, 2023
    Decision Date
    February 16, 2024
    Product Code
    MQC
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQC Mouthguard, Prescription

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    Other Clearances by Formlabs Ohio, Inc.

    K Number Device Name
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