FDAFDA · Alimentos y medicamentos·N.º oficial Z-0013-2022
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Publicado el 13 de octubre de 2021 · Inicio del retiro: 26 de julio de 2021
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Paltop Advanced Dental Solutions Ltd
- Distribuidor
- US Nationwide distribution. No foreign distribution from US.
- Lote
- All lots manufactured prior to July 21, 2021.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Israel
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