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

  • Modèle / numéro de série
    All Lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
  • Description du dispositif
    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
  • 2 Events

Fabricant

  • Adresse du fabricant
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Société-mère du fabricant (2017)
  • Source
    USFDA