Device Recall Maxcem Elite, a dental cement

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 3360900
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
  • 제품 설명
    Brand name: Maxcem Elite, || Product: a dental cement, || Part Number: 34418. || The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Kerr Corporation, 1717 W Collins Ave, Orange CA 92867-5422
  • 제조사 모회사 (2017)
  • Source
    USFDA