Paltop Advanced Dental Solutions Ltd recalls Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical s…

Recall date

July 26, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0013-2022

FDA classification

Class II

Brand / firm

Paltop Advanced Dental Solutions Ltd

Sold / distributed

US Nationwide distribution. No foreign distribution from US.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.