Events

Recall of Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybron Dental Specialties.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60693
  • Event Risk Class
    Class 2
  • Event Number
    Z-0990-2012
  • Event Initiated Date
    2011-03-03
  • Event Date Posted
    2012-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107262
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Material, tooth shade, resin - Product Code EBF
  • Reason
    The recall was initiated because pentron clinical has confirmed that the flow tec nano-hybrid flowable composite material has been found to be difficult to extrude.
  • Action
    Pentron Clinical sent an initial "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and fax back an enclosed recall return form in order to confirm their receipt of the recall notification. A second "URGENT: MEDICAL DEVICE RECALL" letter dated November 10, 2011 was sent to all affected customers because Pentron Clinical expanded the recall. On December 8, 2011 another recall communication was forwarded to all affected customers to change the wording on the letter to make it more clear to the customers about the recall expansion. Contact Pentron Clinical Customer Service at 1-800-551-0283 for questions regarding this recall.

Device

Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)
  • Model / Serial
    All Lots
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
  • Product Description
    Flow Tec Nano-Hybrid Flowable Affected Product || Syringe Part No. Value Pack Part. No. Shade || BEN3784-514 BEN3786-754 A1 || BEN3784-532 BEN3786-763 A2 || BEN3784-541 BEN3784-738 A3 || BEN3784-550 BEN3784-747 A3.5 || BEN3784-569 BEN3784-756 A4 || BEN3784-578 BEN3784-765 B1 || BEN3784-596 BEN3784-774 B2 || BEN3784-603 BEN3784-783 C1 || BEN3784-612 BEN3784-792 C2 || BEN3784-621 BEN3784-809 C3 || BEN3784-649 BEN3784-818 D2 || BEN3784-722 BEN3784-818 Universal Opaque || BEN3784-685 BEN3784-827 A0 || BEN3784-701 BEN3784-836 Incisal. || The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Manufacturer Address
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA