FDAJuly 26, 2021device

Scan Abutment NP, Cat. No. 30-70102 - 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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

paltop advanced dental solutionspaltoppaltop advanced

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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