Lower risk Medical device recall · FDA · Published July 26, 2021

Paltop Scan Abutment SP: 2-Degree Orientation Deviation May Delay Dental Restorations

Paltop Advanced Dental Solutions recalls Scan Abutment SP (Cat. No. 30-70101) made before July 21, 2021 due to possible 2-degree orientation errors that could delay dental restorations. Affected users should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0013-2022Medical device Paltop ›

Lower-risk 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.

Take action

Contact the company

Recalling firmPaltop Advanced Dental Solutions Ltd5, Ha-Shita · Caesarea, Israel

✎ GovInfoNow plain-language explainer

Paltop recalls Scan Abutment SP dental impression devices made before July 21, 2021 because they may have orientation errors that delay dental restorations. This issue does not cause injury but could affect treatment timing. Read more at govinfonow.com/recall/62149-paltop-scan-abutment-sp-2-degree-orientation-deviation-may-delay.

Source Summary by GovInfoNow · govinfonow.com/recall/62149-paltop-scan-abutment-sp-2-degree-orientation-deviation-may-delay · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0013-2022

Cite this page

“Paltop Scan Abutment SP: 2-Degree Orientation Deviation May Delay Dental Restorations.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62149-paltop-scan-abutment-sp-2-degree-orientation-deviation-may-delay. Based on FDA recall #Z-0013-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0013-2022%22&limit=1).

Paltop Advanced Dental Solutions Ltd recalled Scan Abutment SP, Cat. No. 30-70101, manufactured prior to July 21, 2021, according to the FDA on July 26, 2021. The devices may have orientation deviations that could delay final restoration.

How to tell if you have it

Brand: Paltop
Product: Scan Abutment SP
Catalog No.: 30-70101
Manufacture date: Prior to July 21, 2021

The hazard

Context

GovInfoNow's records show Paltop Advanced Dental Solutions Ltd has two other recalls on record since May 30, 2019. On Nov. 18, 2019, the company recalled Dynamic Dental Implants due to wrong screw package hazards. Other recent recalls of similar products include U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026) and Straumann Dental Implant Abutments Recalls (March 27, 2026).

How to tell if you have this one

Check for the product name 'Scan Abutment SP' with catalog number 30-70101. Devices manufactured before July 21, 2021 are affected.

Brand
Paltop
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution. No foreign distribution from US.

Recall number	Product, codes & lots	Quantity
Z-0013-2022	Scan Abutment SP, Cat. No. 30-70101 - 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.; All lots manufactured prior to July 21, 2021.	782
Z-0014-2022	Scan Abutment NP, Cat. No. 30-70102 - 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.; All lots manufactured prior to July 21, 2021.	354
Z-0015-2022	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.; All lots manufactured prior to July 21, 2021.	337
Z-0016-2022	Scan Abutment SU, Cat. No. 30-70104 - 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.; All lots manufactured prior to July 21, 2021.	16
Z-0017-2022	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.; All lots manufactured prior to July 21, 2021.	68
Z-0018-2022	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.; All lots manufactured prior to July 21, 2021.	236

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Paltop Advanced Dental Solutions for specific details about your device and next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution. No foreign distribution from US.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Jul 26, 2021Firm started the recall
Oct 4, 2021FDA classified it Class II
Oct 13, 2021Published in FDA’s Enforcement Report
Sep 21, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62149-paltop-scan-abutment-sp-2-degree-orientation-deviation-may-delay">Paltop Scan Abutment SP: 2-Degree Orientation Deviation May Delay Dental Restorations (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0013-2022 (July 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0013-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.