Class II — Paltop Advanced Dental Solutions Ltd
| Recalling firm | Paltop Advanced Dental Solutions Inc. |
|---|---|
| Registered facility | PALTOP ADVANCED DENTAL SOLUTIONS LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Scan Abutment WP, Cat. No. 30-70106 - 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. |
| Quantity | 236 |
| Distribution | US Nationwide distribution. No foreign distribution from US. |
| Initiated | 2021-07-26 |
| Classified | 2021-10-04 |
| Terminated | 2023-09-21 |
| Recall number | Z-0018-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Paltop Advanced Dental Solutions Ltd (Z-0018-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88576/
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