BEUDAMED
    FDA Enforcement Class II Ongoing

    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

    Recall: Z-0746-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0746-2022
    Event ID
    89534
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Envisiontec US Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2022
    Initiation Date
    January 20, 2022
    Classification Date
    March 10, 2022
    Address
    15162 S Commerce Dr, N/A, Dearborn, MI, 48120-1237, United States

    Description

    PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

    Reason

    The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

    Code Info

    All units SKU number ACC-06-1000

    Distribution

    US Nationwide

    Quantity

    172 units