Scan Abutment PCA, Cat. No. 30-70105 - 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.
Enforcement
- Recall Number
- Z-0017-2022
- Event ID
- 88576
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Paltop Advanced Dental Solutions Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 13, 2021
- Initiation Date
- July 26, 2021
- Classification Date
- October 4, 2021
- Termination Date
- September 21, 2023
- Address
- 5, Ha-Shita, Caesarea, N/A, Israel
Description
Scan Abutment PCA, Cat. No. 30-70105 - 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.
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.
All lots manufactured prior to July 21, 2021.
US Nationwide distribution. No foreign distribution from US.
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