FDA Registration Active 🇮🇱 Israel

PALTOP ADVANCED DENTAL SOLUTIONS LTD

Reg #: 3009161350 · FEI: 3009161350 · Expires 2026
Products
15
Proprietary Names
216
Establishment Types
4
Classifications
15

Registration Details

Registration Name
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Registration Number
3009161350
FEI Number
3009161350
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Hashita 5, Industrial Park
City
Caesarea Central
Country
IL

Regulatory Submissions

510(k) Number
K210117

Owner / Operator

Firm Name
Paltop Advanced Dental Solutions Inc.
Operator Number
10043196
Address
13645 Alton Pkwy Ste A
City
Irvine
State
CA
Postal Code
92618
Country
US

Products

Device Name Product Code
Gauge, Depth, Instrument, Dental EIL
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Denture, Plastic, Teeth ELM
Drill, Dental, Intraoral DZA
Teeth, Porcelain ELL
Controller, Foot, Handpiece And Cord EBW
Handpiece, Contra- And Right-Angle Attachment, Dental EGS
Handpiece, Rotary Bone Cutting KMW
Bur, Dental EJL
Handle, Instrument, Dental EJB
Accessories, Implant, Dental, Endosseous NDP
Attachment, Precision, All EGG
Anchor, Preformed EJX
Instruments, Dental Hand DZN

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 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 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 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 PrimaConnex Ceramic Abutments Paltop Dental Implant System Bone Profiler Kit Bone Profiler Cassette Fully Guided Sleeve Digital Guidance Sleeve (DGS) Excess Bone Remover Kit Basic Complete Surgical Kit Fully Guided Surgical Kit Mill Lab Analog Open Tray Impression Coping Screw I-HEXMRT Surgical Kit Open Tray Multi-Unit Impression Coping Screw Screw Removal Kit Paltop Equator Impression Coping Open Tray Impression coping Prima Plus Guided Surgical Kit Drill Stop Kit Multi-Unit Digital Analog Digital Castable Sleeve Nylon Ball Abutment Retentive Cap Paltop LOC Impression Coping Stainless Steel Ball Abutment Housing Open Tray Multi-Unit Impression Coping Screw Sleeve Closed Tray Multi-Unit Impression Coping-Obsolete Parallel Pin Tissue Support Guided Pin Sleeve Stainless Steel Paltop Equator Housing Digital Analog Final Drill Stop Digital Guidance Sleeve (DGS) Support Open Tray Single-Unit Impression Coping Paltop Equator Retentive Cap Assortment Kit Pin Fixation for Full Guided Surgery Triangular Drill Stop Kit Premium Surgical Kit Prosthetic Kit Empty Basic Surgical Box Closed Tray Single-Unit Impression Coping Bone Profiler Post Implant Kit Paltop LOC Female Analog Surgical Kit for DIVA by Paltop Implant Step Drill Stop PrimaConnex Internal Connection Prosthetics Paltop Equator Protective Disc Closed Tray Multi-Unit Impression Coping Empty Small Surgical Box Pilot Guided Sleeve TiLobeMAXX™ Surgical Kit Muli-Unit Scan Abutment Large Complete Surgical Kit Single-Unit Scan Abutment Guided Surgical Sleeve Multi-Unit Analog Screw Tap Repair Drill Guide Trepan for Bone Remover Implant Analog Small Surgical Box Implant Hex Positioning Kit Large Surgical Kit Abutment Analog O-Ring XL Surgical Kit Open Tray MU/SU Impression Coping Screw Paltop LOC Male Processing Package Compact Surgical Kit Paltop Equator Retentive Cap Protective Abutment Apron Rapid Surgical Kit Pin Fixation Threaded Genesis Guided Surgical Kit LOCATOR Male Processing Package Basic Osteotome Kit Scan Abutment Paltop Equator Analog Plastic Snap-On Closed Tray Impression Coping Parallel Pin Kit Contra Angle Adaptor Closed Tray Multi-Unit Screw Ridge Expansion Kit Open Tray Multi-Unit Impression Coping Locator Replace Male Implant Body Try-In Kit Abutment Lab Screw Angulated Indicator Closed Tray Impression Coping Screw Bone Profiler Post Implant Pin Drill Extender Stepped Depth Pin LOCATOR Female Analog Digital Analog Screw Straight Rod for Profile Gauges Single-Unit Analog Empty Large Surgical Box LOCATOR Impression Coping Tissue Support Guided Pin Ball Abutment Analog Single-Unit Digital Analog Closed Tray Impression coping Final Depth Pin Guided Anchor Pin Bone Profiler Post Implant Set Empty Premium Surgical Box (Grommetless) Bone Profiler Guide Pin Abutment Retrieval Tool Set Ball Abutment Attachments LOCATOR® Abutments and Accessories Extractor for Abutment Screw Quad Driver Prima Plus Implant Driver Torque Ratchet Core Tool Hand Piece Straight Key Ratchet Adapter Guide Handle Implant Hex Positioning Key Hex Key Insertion Bit Hex Key Ratchet Adapter Ratchet Implant Insertion Key Manual Hex Driver Extractor Abutment Screw Retrieval Instrument TiLobe® Guided Implant Driver Hex Driver Prima Surgical Hand Driver Conversion Handle For Latch Type Guided Implant Driver

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device