BEUDAMED
    FDA Enforcement Class II Terminated

    Dharma Cavity Varnish with Fluoride

    Recall: Z-0475-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0475-2015
    Event ID
    69386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dharma Research, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    September 29, 2014
    Classification Date
    November 26, 2014
    Termination Date
    October 3, 2016
    Address
    5220 Nw 72nd Ave, Bay 15, Miami, FL, 33166-4860, United States

    Description

    Dharma Cavity Varnish with Fluoride

    Reason

    During an FDA inspection, it was found that the products are being marketed without a cleared 510k.

    Code Info

    All Lots - Item #14-00015

    Distribution

    Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.

    Quantity

    2,842