Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel
Lot Codes / Batch Numbers
All lots manufactured prior to July 21, 2021.
Products Sold
All lots manufactured prior to July 21, 2021.
Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel is recalling Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral due to 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 inc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Impacted customers were contacted on July 26, 2021 via overnight delivery of written notification. The firm is replacing all components listed in the recall, purchased prior to 7/21/2021. Customers were asked to complete and return the provided product replacement form. A customer service representative will contact you to evaluate your inventory and to facilitate the exchange immediately. Please contact your Customer Service Department at 866-902-9272 for any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026