Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0014-2022 — 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 app

U.S. FDA — Device Enforcement · Israel · 2021-07-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0014-2022
Date of alert
2021-07-26
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Paltop Advanced Dental Solutions Ltd
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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