Manufacturer registered with FDA
Paltop Advanced Dental Solutions Inc.
Irvine, CA, United States. Lists 15 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 15
- Brands and models
- 259
- 510(k) clearances
- 72012–2025
- Markets registered in
- 5122 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Paltop Advanced Dental Solutions Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Paltop Advanced Dental Solutions Inc. | 7 clearances | 2012–2025 | Below |
| Colombia | INVIMA | Registration holder | PALTOP ADVANCED DENTAL SOLUTIONS INCPALTOP ADVANCED DENTAL SOLUTIONS LTD. | 108 | — | Pure Global AI |
| Israel | AMAR | Registration holder | PALTOP ADVANCED DENTAL SOLUTIONS LTD.Paltop Advanced Dental Solutions Inc. | 12 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Paltop Advanced Dental Solutions Inc. | 1 | 2021–2021 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PALTOP ADVANCED DENTAL SOLUTIONS INC. | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Paltop Advanced Dental Solutions Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Advanced + Dental Implant SystemAdvanced + Dia 3.25mm Dental Implant SystemAdvanced + NP Dental SystemAdvanced Dia 3.25mm Dental Implant SystemAdvanced NP Dental SystemDynamic Conical Implant SystemDynamic Dia 3.25mm Dental Implant SystemDynamic NP Dental SystemGenesis ACTIVE Implant SystemGenesis Implant System 30 moreI-HEXMRT Dental Implant SystemIHEXMRT Dental Implant SystemKDG AbutmentsLOCATOR® Abutments and AccessoriesMAX-TL Abutment SystemMAX-TL Dental Implant SystemMulti-Unit Abutments and AccessoriesPAI Dental Implant SystemPAI Dia 3.25mm Dental Implant SystemPAI Total Coverage (TC) Dental Implant SystemPAI Total Coverage (TC) Dia 3.25mm Dental Implant SystemPaltop Advanced Dental Implant SystemPaltop Conical Implant SystemPaltop Dental Implant SystemPaltop Dental Sterile AccessoriesPaltop Dynamic Dental Implant System,Paltop Narrow ImplantPaltop PCA dental implant systemPaltop Short ImplantsPCA Implant SystemPrima Plus Dental Implant SystemPrimaConnex CAD/CAM Abutment SystemPrimaConnex Ceramic AbutmentsPrimaConnex Dental Implant SystemPrimaConnex RD Esthetic Contour Zi AbutmentsPrimaConnex SD Esthetic Contour Zi AbutmentsPrimaConnex WD Esthetic Contour Zi AbutmentsSingle-Unit AbutmentsTiLobe Abutment SystemTiLobeMAXX Abutment System | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Advanced + Dental Implant SystemAdvanced + Dia 3.25mm Dental Implant SystemAdvanced + NP Dental SystemAdvanced Dia 3.25mm Dental Implant SystemAdvanced NP Dental SystemDynamic Conical Implant SystemDynamic Dia 3.25mm Dental Implant SystemDynamic NP Dental SystemGenesis ACTIVE Implant SystemGenesis Implant System 25 moreI-HEXMRT Dental Implant SystemIHEXMRT Dental Implant SystemMAX-TL Abutment SystemMAX-TL Dental Implant SystemPAI Dental Implant SystemPAI Dia 3.25mm Dental Implant SystemPAI Total Coverage (TC) Dental Implant SystemPAI Total Coverage (TC) Dia 3.25mm Dental Implant SystemPaltop Advanced Dental Implant SystemPaltop Conical Implant SystemPaltop Dental Implant SystemPaltop Dental Sterile AccessoriesPaltop Dynamic Dental Implant System,Paltop Narrow ImplantPaltop PCA dental implant systemPaltop Short ImplantsPCA Implant SystemPrima Plus Conical Implant SystemPrima Plus Dental Implant SystemPrimaConnex Dental Implant SystemPrimaConnex Dental ImplantsPrimaSolo Dental ImplantsRENOVA Dental ImplantsTiLobe Abutment SystemTiLobeMAXX Abutment System | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Abutment Screw Reverse DrillBone ProfilerBone Profiler Post ImplantBone Profiler Pre-ImplantBone TapBone Tap KitCountersinkCountersink KitFinal DrillFixation Pin Drill 28 moreFully Guided DrillGenesis Implant SystemGuided CountersinkGuided Initial Step DrillGuided Pilot DrillInitial DrillInitial Drill for Genesis ImplantsInitial Drill for Prima ImplantsOsteotomeOsteotome for DIVAOsteotome KitPilot Drill SpadePilot Guided DrillPilot Guided Drill KitPilot Guided Drill SpadePlilot Drill SpadePrima Dental Implant SystemPrima Plus Dental Implant SystemShaped DrillShort Step Drill KitSinus Floor Break OsteotomeStep DrillSurgical TapTapered DrillTapered TapTissue PunchTwist DrillWide Implant Drill Kit | 2020 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Abutment Screw Retrieval InstrumentConversion Handle For Latch TypeCore ToolExtractorExtractor for Abutment ScrewGenesis Implant SystemGuide HandleGuided Implant DriverHand Piece StraightHex Driver 15 moreHex KeyHex Key Insertion BitI-HEXMRT Dental Implant SystemImplant Hex Positioning KeyImplant Insertion KeyKey Ratchet AdapterManual Hex DriverPrima Dental Implant SystemPrima Plus Implant DriverPrima Surgical Hand DriverQuad DriverRatchetRatchet AdapterTiLobe® Guided Implant DriverTorque Ratchet | 2020 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | Contra Angle NSK | 2021 |
| All Precision AttachmentEGG · Class 1 | — | Lister | Ball Abutment Attachments | 2025 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Contra Angle NSK | 2021 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth GaugeDepth Probe for Prima Implant SystemsDrill Depth ProbeProfile GaugeProfile Gauge for MAXX Implants | 2020 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Manual Handle | 2020 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Round Burr | 2020 |
| Preformed AnchorEJX · Class 1 | — | Maker | — | 2024 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | PrimaConnex CAD/CAM Abutment System | 2022 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | POP (Preformed Ovate Pontic) | 2022 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | Contra Angle NSK | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Analog O-RingAbutment Lab ScrewAbutment Retrieval Tool SetAngulated IndicatorBall Abutment AnalogBasic Complete Surgical KitBasic Osteotome KitBone Profiler CassetteBone Profiler Guide PinBone Profiler Kit 98 moreBone Profiler Post Implant KitBone Profiler Post Implant PinBone Profiler Post Implant SetClosed Tray Impression copingClosed Tray Impression Coping ScrewClosed Tray Multi-Unit Impression CopingClosed Tray Multi-Unit Impression Coping-ObsoleteClosed Tray Multi-Unit ScrewClosed Tray Single-Unit Impression CopingCompact Surgical KitContra Angle AdaptorDigital AnalogDigital Analog ScrewDigital Castable SleeveDigital Guidance Sleeve (DGS)Digital Guidance Sleeve (DGS) SupportDrill ExtenderDrill GuideDrill Stop KitEmpty Basic Surgical BoxEmpty Large Surgical BoxEmpty Premium Surgical Box (Grommetless)Empty Small Surgical BoxExcess Bone Remover KitFinal Depth PinFinal Drill StopFully Guided SleeveFully Guided Surgical KitGenesis Guided Surgical KitGenesis Implant SystemGuided Anchor PinGuided Surgical SleeveI-HEXMRT Dental Implant SystemI-HEXMRT Surgical KitImplant AnalogImplant Body Try-In KitImplant Hex Positioning KitLarge Complete Surgical KitLarge Surgical KitLOCATOR Female AnalogLOCATOR Impression CopingLOCATOR Male Processing PackageLocator Replace MaleMAX-TL Dental Implant SystemMill Lab AnalogMuli-Unit Scan AbutmentMulti-Unit AnalogMulti-Unit Digital AnalogNylon Ball Abutment Retentive CapOpen Tray Impression copingOpen Tray Impression Coping ScrewOpen Tray MU/SU Impression Coping ScrewOpen Tray Multi-Unit Impression CopingOpen Tray Multi-Unit Impression Coping ScrewOpen Tray Multi-Unit Impression Coping Screw SleeveOpen Tray Single-Unit Impression CopingPaltop Equator AnalogPaltop Equator Impression CopingPaltop Equator Protective DiscPaltop Equator Retentive CapPaltop Equator Retentive Cap Assortment KitPaltop LOC Female AnalogPaltop LOC Impression CopingPaltop LOC Male Processing PackageParallel PinParallel Pin KitPilot Guided SleevePin Fixation for Full Guided SurgeryPin Fixation ThreadedPlastic Snap-On Closed Tray Impression CopingPremium Surgical KitPrima Dental Implant SystemPrima Plus Guided Surgical KitPrimaConnex Internal Connection ProstheticsProsthetic KitProtective Abutment ApronRapid Surgical KitRidge Expansion KitScan AbutmentScrew Removal KitScrew Tap RepairSingle-Unit AnalogSingle-Unit Digital AnalogSingle-Unit Scan AbutmentSmall Surgical BoxStainless Steel Ball Abutment HousingStainless Steel Paltop Equator HousingStep Drill StopStepped Depth PinStraight Rod for Profile GaugesSurgical Kit for DIVA by Paltop ImplantTiLobe Abutment SystemTiLobeMAXX Surgical KitTissue Support Guided PinTissue Support Guided Pin SleeveTrepan for Bone RemoverTriangular Drill Stop KitXL Surgical Kit | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Paltop Advanced Dental Solutions Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Sep 2025 | K243983 | Paltop Dental Implant System | DZE Root-Form Endosseous Implant |
| 22 May 2024 | K232740 | Paltop Short Implants | DZE Root-Form Endosseous Implant |
| 25 May 2022 | K220200 | Paltop Conical Implant System | DZE Root-Form Endosseous Implant |
| 30 Nov 2021 | K210117 | Paltop Narrow Implant | DZE Root-Form Endosseous Implant |
| 27 Aug 2013 | K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | DZE Root-Form Endosseous Implant |
| 22 Aug 2013 | K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | DZE Root-Form Endosseous Implant |
| 20 Apr 2012 | K112795 | PALTOP DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Manufacturera Dental Continental (3), Smart Denture Conversions, LLC (1).
Also lists devices cleared under other names
Paltop Advanced Dental Solutions Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Keystone Dental Inc. (1), Nakanishi, Inc. (1), Zest Anchors, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Aug 2022 | K221381 | KDG Abutments | Keystone Dental Inc. | NHA Endosseous Dental Implant Abutment |
| 19 Jun 2018 | K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 3 Dec 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PALTOP ADVANCED DENTAL SOLUTIONS LTDFDA reg. 3009161350 | Caesarea Central, Israel | Contract manufacturer, Foreign exporter, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043196). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.