Data / Medical devices / Israel / Paltop Advanced Dental Solutions Ltd
Paltop Advanced Dental Solutions Ltd: FDA-registered device maker in Caesarea Central, Israel, 10 510(k) clearances
Paltop Advanced Dental Solutions Ltd is registered with the FDA (registration 3009161350) in Caesarea Central, Israel. It lists 15 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 29, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009161350
- Address
- Hashita 5, Industrial Park, Caesarea Central, Israel, 3088900
- Owner or operator
- Paltop Advanced Dental Solutions Inc. (10043196)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- January 30, 2013
- Registered through
- 2026
- Brand names listed
- Abutment Analog O-Ring, Abutment Lab Screw, Abutment Retrieval Tool Set, Abutment Screw Retrieval Instrument, Abutment Screw Reverse Drill, Advanced + Dental Implant System, Advanced + Dia 3.25mm Dental Implant System, Advanced + NP Dental System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2025 | K243983 | Paltop Dental Implant System | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| May 22, 2024 | K232740 | Paltop Short Implants | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| August 10, 2022 | K221381 | KDG Abutments | NHA | Substantially Equivalent | Keystone Dental, Inc. | accessdata.fda.gov |
| May 25, 2022 | K220200 | Paltop Conical Implant System | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| November 30, 2021 | K210117 | Paltop Narrow Implant | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| June 19, 2018 | K173905 | Surgic Pro, Surgic Pro+ | EBW | Substantially Equivalent | Nakanishi, Inc. | accessdata.fda.gov |
| August 27, 2013 | K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| August 22, 2013 | K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| April 20, 2012 | K112795 | PALTOP DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Paltop Advanced Dental Solutions, Ltd. | accessdata.fda.gov |
| December 3, 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | NHA | Substantially Equivalent | Zest Anchors, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 26, 2021 | 88576 | Class II | Terminated | 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 Dent | 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. | accessdata.fda.gov |
| November 18, 2019 | 84412 | Class II | Terminated | Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 | 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. | accessdata.fda.gov |
| May 30, 2019 | 83198 | Class II | Terminated | Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Controller, Foot, Handpiece And Cord
- All makers of Handpiece, Rotary Bone Cutting
- All makers of Bur, Dental
Updated September 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.