BEUDAMED
    FDA Recall Open, Classified

    CustMbite, Model Number CBT-SRS-UL

    Recall: Z-1494-2022 · Initiated May 23, 2022

    Recall

    Recall Number
    Z-1494-2022
    Event Number
    90639
    Firm
    Dental Choice Holding Llc
    FEI Number
    3017968320
    Product Code
    LRK
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 23, 2022
    Address
    10100 Linn Station Rd, Louisville, KY, 40223-3861

    Description

    CustMbite, Model Number CBT-SRS-UL

    Reason

    The device was marketed and sold in the US without FDA clearance.

    Action

    Firm began notifying customers via recall letters on 5/23/22 and 6/6/22. A second round of letters was sent on 6/30/22 non-responding customers. Customers are instructed to cease use of the product and to discard it immediately. The firm will provide a full refund to affected customers. To receive a full refund of the purchase price, please contact Dental Choice Holdings Customer Service between the hours of 9am and 5pm Eastern Standard Time at 1-(855)-253-4680 or send an email to [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    708