Device Recall Bond1 Primer/Adhesive

  • 모델명 / 제조번호(시리얼번호)
    Lots 186620, 190582 and 190985.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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