Device Recall Straumann Standard Plus Implant

  • 모델명 / 제조번호(시리얼번호)
    Lot No. CW642
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Straumann Standard Plus Implant 04.8mm Wide Neck || SLA 10mm || Article Number: 043.652S. || Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Straumann USA, LLC, 60 Minuteman Rd, Andover MA 01810-1008
  • 제조사 모회사 (2017)
  • Source
    USFDA