Devices

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.

  • Model / Serial
    Part Number Part Description Lot Number Label Form Actual Form 11100141124 SE Niti 014 Nat U 100 41756 Upper Lower 11100141144 SE Niti 014 Nat L 100 41760 Lower Upper 11100141145 SE Niti 014 Nat L 10 41760 Lower Upper
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
  • Product Description
    SuperElastic Regular force NiTi lower or upper Natural arches. || 0.14 size || 10 or 100 count packages. || Highland Metals Inc. || San Jose, CA || The devices are intended to provide force to the teeth to effect movement in order to alter their position.
  • Manufacturer
    Highland Metals, Inc.
  • 1 Event

Manufacturer

Highland Metals, Inc.
  • Manufacturer Address
    Highland Metals, Inc., 419 Perrymont Ave, San Jose CA 95125-1445
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall SuperElastic Regular force NiTi lower or upper Natural arches.
  • Model / Serial
    Part Number Part Description Lot Number Label Form Actual Form 11100161124 SE Niti 016 Nat U 100 41684 Upper Lower 11100161125 SE Niti 016 Nat U 10 41684 Upper Lower 11100161144 SE Niti 016 Nat L 100 41679 Lower Upper
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
  • Product Description
    SuperElastic Regular force NiTi lower or upper Natural arches. || 0.16 size || 10 or 100 count packages. || Highland Metals Inc. || San Jose, CA || The devices are intended to provide force to the teeth to effect movement in order to alter their position.
  • Manufacturer
    Highland Metals, Inc.