BEUDAMED
    FDA Enforcement Class II Terminated

    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry

    Recall: Z-1034-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1034-2017
    Event ID
    76039
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 14, 2016
    Classification Date
    January 17, 2017
    Termination Date
    June 5, 2017
    Address
    505 W 10200 S, South Jordan, UT, 84095-3800, United States

    Description

    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry

    Reason

    Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.

    Code Info

    Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ

    Distribution

    Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.

    Quantity

    143 packs of 100 tips; 104 packs of 20 tips