PALTOP ADVANCED DENTAL SOLUTIONS LTD

FDA Device Registration & Listing · Caesarea Central, IL · Registration 3009161350

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009161350
FEI Number
3009161350
Entity Name
PALTOP ADVANCED DENTAL SOLUTIONS LTD
City/State/Country
Caesarea Central, IL
Establishment Address
Hashita 5, Industrial Park, Caesarea Central 3088900, IL
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Paltop Advanced Dental Solutions Inc. (Owner Number: 10043196)
Owner / Operator Contact Address
13645 Alton Pkwy Ste A, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Depth Probe for Prima Implant Systems Profile Gauge for MAXX Implants Profile Gauge Drill Depth Probe Depth Gauge Genesis Implant System Advanced + NP Dental System Dynamic NP Dental System Advanced NP Dental System Paltop Narrow Implant Paltop Dental Sterile Accessories Genesis Implant System RENOVA Dental Implants PrimaConnex Dental Implants PrimaSolo Dental Implants POP (Preformed Ovate Pontic) Prima Dental Implant System Pilot Guided Drill Kit Pilot Guided Drill Bone Profiler Post Implant Tissue Punch Shaped Drill Abutment Screw Reverse Drill Osteotome for DIVA Osteotome Twist Drill Guided Countersink Short Step Drill Kit Plilot Drill Spade Fully Guided Drill Prima Plus™ Dental Implant System Pilot Drill Spade Bone Tap Sinus Floor Break Osteotome Initial Drill for Prima Implants Final Drill Step Drill Bone Profiler Pre-Implant Countersink Kit Tapered Drill Pilot Guided Drill Spade Wide Implant Drill Kit Guided Initial Step Drill Genesis Implant System Countersink Guided Pilot Drill Osteotome Kit Initial Drill for Genesis Implants Fixation Pin Drill Bone Tap Kit Tapered Tap Initial Drill Surgical Tap Bone Profiler PrimaConnex CAD/CAM Abutment System I-HEXMRT Dental Implant System MAX-TL Dental Implant System Genesis ACTIVE Implant System PCA Implant System Dynamic Conical Implant System Paltop Conical Implant System PAI Total Coverage (TC) Dia 3.25mm Dental Implant System Advanced + Dia 3.25mm Dental Implant System Advanced Dia 3.25mm Dental Implant System Paltop Narrow Implant PAI Dia 3.25mm Dental Implant System Dynamic Dia 3.25mm Dental Implant System Paltop PCA dental implant system Contra Angle NSK TiLobe Abutment System Prima Plus Dental Implant System PrimaConnex Dental Implant System Prima Plus Conical Implant System Paltop Advanced Dental Implant System Paltop Dynamic Dental Implant System, PAI Total Coverage (TC) Dental Implant System Advanced + Dental Implant System PAI Dental Implant System Round Burr TiLobeMAXX Abutment System IHEXMRT Dental Implant System MAX-TL Abutment System Paltop Short Implants Manual Handle KDG Abutments Multi-Unit Abutments and Accessories Single-Unit Abutments PrimaConnex SD Esthetic Contour Zi Abutments PrimaConnex WD Esthetic Contour Zi Abutments PrimaConnex RD Esthetic Contour Zi Abutments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2020-07-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-07-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-07-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-12-05
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-12-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-11-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-11-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-07-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-07-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-08-31
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2022-05-01
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2020-06-29
ELL Teeth, Porcelain Dental Class 2 872.3920 2022-08-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-08-31
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-07-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-07-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-06-05
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-06-05
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-05-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-05-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-11-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-11-06
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2021-04-14
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2021-04-14
KMW Handpiece, Rotary Bone Cutting Dental Class 2 872.4120 2021-04-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-07-20
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-07-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-07-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-01-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-01-30
EJL Bur, Dental Dental Class 1 872.3240 2020-07-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2020-10-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-10-09
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-05-23
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-05-23
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2020-07-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-08-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-08-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

Brian Lanza Email: BLanza@keystonedental.com Phone: (866) 9029272

Related Public Records

Same Entity

Paltop Advanced Dental Solutions Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01
K925778 Nobelpharma USA, Inc. BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES 1993-04-14
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
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.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
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.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
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.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
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.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
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.
Z-0018-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
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.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009161350. Last updated year: 2026. Please use registration number 3009161350 when referencing this establishment in official correspondence.
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