Paltop Advanced Dental Solutions Ltd
Caesarea Central, IL
PALTOP ADVANCED DENTAL SOLUTIONS LTD appears in FDA device records in Caesarea Central, IL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Paltop Advanced Dental Solutions Ltd between 2012 and 2025. The busiest year on record is 2013, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2013 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243983 | Paltop Dental Implant System | DZE | Substantially Equivalent | |
| K232740 | Paltop Short Implants | DZE | Substantially Equivalent | |
| K220200 | Paltop Conical Implant System | DZE | Substantially Equivalent | |
| K210117 | Paltop Narrow Implant | DZE | Substantially Equivalent | |
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | DZE | Substantially Equivalent | |
| K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | DZE | Substantially Equivalent | |
| K112795 | PALTOP DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009161350 | 3009161350 | PALTOP ADVANCED DENTAL SOLUTIONS LTD | Hashita 5, Industrial Park, Caesarea Central 3088900 IL | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EJXAnchor, Preformed
- EGGAttachment, Precision, All
- EJLBur, Dental
- EBWController, Foot, Handpiece And Cord
- ELMDenture, Plastic, Teeth
- DZADrill, Dental, Intraoral
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- KMWHandpiece, Rotary Bone Cutting
- DZEImplant, Endosseous, Root-Form
- DZNInstruments, Dental Hand
- ELLTeeth, Porcelain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | 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. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| Z-0836-2020 | 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. | Class II | Terminated | |
| Z-0019-2020 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain