BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Prima Plus Guided Surgical Kit

    Reg #: 3009161350 · FEI: 3009161350 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    106
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PALTOP ADVANCED DENTAL SOLUTIONS LTD
    Registration Number
    3009161350
    FEI Number
    3009161350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hashita 5, Industrial Park
    City
    Caesarea Central
    Country
    IL

    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
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Prima Plus Guided Surgical Kit LOCATOR Male Processing Package MAX-TL Dental Implant System Implant Body Try-In Kit LOCATOR Female Analog I-HEXMRT Surgical Kit Pin Fixation Threaded Drill Guide Pin Fixation for Full Guided Surgery Prosthetic Kit Digital Guidance Sleeve (DGS) Support PrimaConnex Internal Connection Prosthetics Ball Abutment Analog Parallel Pin Fully Guided Sleeve Rapid Surgical Kit Guided Surgical Sleeve Open Tray Single-Unit Impression Coping Multi-Unit Analog Screw Tap Repair Tissue Support Guided Pin Abutment Lab Screw Large Complete Surgical Kit Angulated Indicator Locator Replace Male Prima Dental Implant System Open Tray Impression coping LOCATOR Impression Coping Screw Removal Kit Scan Abutment Genesis Guided Surgical Kit Implant Analog TiLobeMAXX™ Surgical Kit Straight Rod for Profile Gauges Closed Tray Impression Coping Screw Fully Guided Surgical Kit Digital Analog Drill Stop Kit Multi-Unit Digital Analog Basic Osteotome Kit Trepan for Bone Remover I-HEXMRT Dental Implant System Implant Hex Positioning Kit Parallel Pin Kit STAGE-1 Dental Implant System Paltop Equator Impression Coping XL Surgical Kit Paltop Equator Protective Disc Single-Unit Analog Paltop LOC Female Analog Large Surgical Kit Protective Abutment Apron Basic Complete Surgical Kit RESTORE Dental Implant System Open Tray Multi-Unit Impression Coping Screw Final Depth Pin Genesis Implant System Stainless Steel Paltop Equator Housing Compact Surgical Kit Nylon Ball Abutment Retentive Cap Plastic Snap-On Closed Tray Impression Coping Paltop Equator Analog Paltop LOC Impression Coping Stainless Steel Ball Abutment Housing Tissue Support Guided Pin Sleeve Surgical Kit for DIVA by Paltop Implant Closed Tray Multi-Unit Impression Coping-Obsolete Contra Angle Adaptor Closed Tray Multi-Unit Screw Drill Extender Abutment Analog O-Ring Closed Tray Single-Unit Impression Coping Bone Profiler Post Implant Kit Premium Surgical Kit Small Surgical Box Paltop Equator Retentive Cap Assortment Kit Open Tray Impression Coping Screw Triangular Drill Stop Kit Digital Castable Sleeve Final Drill Stop Mill Lab Analog Open Tray Multi-Unit Impression Coping Screw Sleeve Single-Unit Scan Abutment Empty Large Surgical Box Digital Analog Screw Muli-Unit Scan Abutment TiLobe Abutment System Bone Profiler Post Implant Pin Paltop Equator Retentive Cap Open Tray Multi-Unit Impression Coping Paltop LOC Male Processing Package Excess Bone Remover Kit Pilot Guided Sleeve Empty Small Surgical Box Open Tray MU/SU Impression Coping Screw Single-Unit Digital Analog Closed Tray Impression coping Step Drill Stop Empty Basic Surgical Box Ridge Expansion Kit Stepped Depth Pin Closed Tray Multi-Unit Impression Coping Digital Guidance Sleeve (DGS) Bone Profiler Post Implant Set Guided Anchor Pin Empty Premium Surgical Box (Grommetless)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device