Recall Z-0015-2022— Paltop Advanced Dental Solutions Ltd
Class II · Terminated
Class II FDA medical device recall by Paltop Advanced Dental Solutions Ltd, initiated 2021-07-26, terminated 2023-09-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Scan Abutment MU, Cat. No. 30-70103 - 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.. 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..
- Recalling firm
- Paltop Advanced Dental Solutions Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-26
- Terminated
- 2023-09-21
- Firm location
- Caesarea, Israel
Product description
Scan Abutment MU, Cat. No. 30-70103 - 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.