Device Recall Prima Plus

  • 모델명 / 제조번호(시리얼번호)
    UDI: D76815737K0, Lot 37038
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
  • 제품 설명
    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K || Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
  • 제조사 모회사 (2017)
  • Source
    USFDA