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Paltop Advanced Dental Solutions Recalls
8 recalls on record · October 9, 2019 to October 13, 2021 · Medical Devices
Recalls by year
19
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 13, 2021Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical s
Hazard: 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.
October 13, 2021Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical
Hazard: 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.
October 13, 2021Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical s
Hazard: 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.
October 13, 2021Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical s
Hazard: 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.
October 13, 2021Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical sc
Hazard: 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.
October 13, 2021Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical sc
Hazard: 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.
January 29, 2020Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Hazard: Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
October 9, 2019Medical DevicesFDA
Paltop Advanced Dental Solutions Ltd recalls Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Hazard: Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.