Z-0017-2022Class II

Scan Abutment PCA, Cat. No. 30-70105 -

Name: Z-0017-2022 Scan Abutment PCA, Cat. No. 30-70105 -
Creator: Paltop Advanced Dental Solutions Ltd
Published: 2021-07-26
License: https://open.fda.gov/license/

Paltop Advanced Dental Solutions Ltd / initiated 2021-07-26 / Terminated

FDA source

Paltop Advanced Dental Solutions Ltd began a recall of 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... on 2021-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0017-2022
Classification: Class II
Status: Terminated
Initiated: 2021-07-26
Posted: 2021-10-04
Terminated: 2023-09-21
Recalling firm: Paltop Advanced Dental Solutions Ltd
Product: 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.
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 68
Distribution: US Nationwide distribution. No foreign distribution from US.
Product codes and lots: All lots manufactured prior to July 21, 2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0017-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0013-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04
Z-0014-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04
Z-0015-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04
Z-0016-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04
Z-0017-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04
Z-0018-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-04

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)