Device Recall Tytin Regular Set

  • 모델명 / 제조번호(시리얼번호)
    Part Number 29948, Lot Number 3-1294. Expires October 2016
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.
  • 제품 설명
    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. || The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Kerr Corporation, 28200 Wick Rd, Romulus MI 48174-2639
  • 제조사 모회사 (2017)
  • Source
    USFDA