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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2020-07-21 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2020-07-20 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-07-20 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2022-05-01 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2020-06-29 |
| Teeth, Porcelain | ELL | Class 2 | Dental | No | 2022-08-31 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2021-04-14 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2021-04-14 |
| Handpiece, Rotary Bone Cutting | KMW | Class 2 | Dental | No | 2021-04-14 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2020-07-22 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2020-07-22 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-07-21 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2025-01-16 |
| Anchor, Preformed | EJX | Class 1 | Dental | No | 2024-08-01 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2020-07-21 |
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