Device Recall Bond1 Primer/Adhesive

  • Modèle / numéro de série
    Item # Bottle Lot # Package Lot# N01I 185597, 192338, 202233 186658, 194491, 202885 N01IAA 185597, 192372 184876, 185342, 192372 N01IAB 183352, 183845, 202233 183466, 183948, 203221 N04 191010 200816 N04B 185597 183127 N31B 184256, 197303 184464, 204774 N33 184256 180766
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Spain, Russia, Finland, England, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Romania, Sweden, and Serbia.
  • Description du dispositif
    Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding || agent. || Item # Item Description || N01I Bond-1 Prim/Adhesive Kit || N01IAA Bond-1 Primer/Adhesive 4ml || N01IAB Bond-1 Primer/Adhesive 6ml || N04 Lute-it w/ Bond-1 kit || N04B Lute-t w/Bond-1 Intro Kit || N31B Bond-1 C&B; Prim/Adhesive || N33 Cement-it Universal C&B; Resin. || The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
  • Manufacturer
  • 1 Event

Fabricant

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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Lots 186620, 190582 and 190985.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
  • Description du dispositif
    Bond-1 Primer/Adhesive. || The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
  • Manufacturer