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

    Dental LT Clear V2 Resin

    K Number: K222061 · Decision Nov 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    3
    Review Days
    120

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    Basic Information

    Device Name
    Dental LT Clear V2 Resin
    K Number
    K222061
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Formlabs Ohio, Inc.
    Date Received
    July 13, 2022
    Decision Date
    November 10, 2022
    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
    K240538 Premium Teeth Resin
    K232087 Dental LT Comfort Resin