Manufacturer registered with FDA
DSI Dental Solutions Ltd
Ashdod, Israel. Lists 24 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 24
- Brands and models
- 40
- 510(k) clearances
- 22020–2025
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name DSI Dental Solutions Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DSI Dental Solutions Ltd | 2 clearances | 2020–2025 | Below |
| United Kingdom | MHRA | Manufacturer | DSI Dental Solutions Ltd | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DSI DENTAL SOLUTIONS LTD. | 1 | — | 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 DSI Dental Solutions Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Sil-FlowUnilite FlowUnilite Flow KitUnilite Universal Composite | 2023 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | DSI Dental Implant System | 2020 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Unilite FlowUnilite Flow KitUnilite Universal Composite | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | DSI Implant Jig Paste Light Cure Pattern Modeling ResinJig Sculpting Light Cure Pattern Modeling ResinUnilite Blockout Material | 2023 |
| Articulation PaperEFH · Class 1 | — | Lister | DSI OccuFoil | 2023 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | — | 2025 |
| Over the Counter Denture CushionEHS · Class 2 | — | Lister | — | 2025 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Unilite Dam Liquid LC Material | 2023 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Plastic Probe | 2023 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | ApexPasteApexPaste BioApexPaste HardApexPaste ICalPaste LC | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | DSI Prophylaxis PastePumice Paste | 2022 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Lister | DSI ApexCream EDTA RC Preparation Cream | 2023 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | UltraSil Heavy Body WashUltraSil Light Body WashUltraSil Putty | 2023 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Glass-FX BioGlass-FX ClearGlass-FX ConditionerGlass-FX Micro | 2022 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | Zoer QuickZOER Reinforced | 2022 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | ApexSil RCApexSil SilverReMTA OneZOER RC Automix | 2022 |
| Disposable Fluoride TrayKMT · Class 1 | — | Lister | Fluoride Gel Tray | 2023 |
| Carboxymethylcellulose Sodium (40-100&) Denture AdhesiveKOQ · Class 1 | — | Lister | — | 2025 |
| Carboxymethylcellulose Sodium or Polyvinyl Methylether Maleic Acid Calcium-SodiumKOT · Class 1 | Denture cleansers & adhesives | Lister | — | 2025 |
| Resin ApplicatorKXR · Class 1 | — | Lister | DSI Veneer Stick Adhesive Tip Holders | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DSI Dental Implant tools and accessories | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DSI Dental Implant System | 2020 |
| Plaque Disclosing AgentQJC · Class 1 | — | Lister | — | 2025 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | DSI Dental Implant Drills | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
DSI Dental Solutions Ltd 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: Prevest Denpro Limited (3), HDI Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Nov 2022 | K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | HDI Inc. | ELW Impression Material |
| 23 Sep 2022 | K213339 | DENU Composite Resin, DENU Flow Resin | HDI Inc. | EBF Resin Tooth Shade Material |
| 23 May 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | KIF Root Canal Filling Resin |
| 13 May 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | EJK Calcium Hydroxide Cavity Liner |
| 13 May 2021 | K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DSI DENTAL SOLUTIONS LTDFDA reg. 3016447764 | Ashdod Southern, Israel | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062297). 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.