Manufacturer registered with FDA
Ditron Dental Ltd
Ashkelon, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 73
- 510(k) clearances
- 22024–2024
- Markets registered in
- 4282 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Ditron Dental Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: IsraelOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ditron Dental Ltd | 2 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Ditron Dental Ltd. | 279 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DITRON DENTAL LTD | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DITRON DENTAL LTD. | 1 | 2020–2020 | 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 Ditron Dental 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment multi post screw, Multi-unit abutment screw, Multi-unit prosthetic screw.Abutment, Implant, Dental EndosseousAccelx cover screwsAccelx dental implantsBar Retained Abutments, Multi-Unit Bar Retained Abutments, Screw Retained Abutment, Cover Screw, Healing CapCastable base abutment (Co- Cr- Mo alloy, Multi-unit abutments, Titanium base abutments, Titanium blank abutments,CC Cement Retained AbutmentsCC Cover ScrewCC Healing CapsCC Liberator Overdenture Abutments 21 moreCC Prosthetic ScrewCC Screw-Retained Abutments (Single-unit Abutments and Multi-Unit Abutments)CC SRA Healing AbutmentsCC SRA Titanium Coping AbutmentsCC Temporary PEEK AbutmentsCC Temporary Titanium AbutmentsCover screws, Healing abutments, Temporary abutments, Prepable straight abutments, Angled abutment,Laser Marked Titanium AbutmentsMilled Abutment, Straight MU Abutment, Liberator AbutmentMPC, APC, UPC, CPC ImplantsMPI 6mm, MPI OD3.3mm, ULT, APIMPI, CPI, OPIRecover Cover Screw (NP & RP), Rapid Cover Screw (NP & RP)Reflect Recover Implant (NP & RP), Reflect Rapid Implant (NP & RP)Straight Abutment, Anatomic Angulated Abutment, Angulated Abutments, Ball Retained Abutments, Temporary AbutmentsTiN Coated Overdenture AbutmentsTiN Coated TLI Liberator and TLI Overdenture AbutmentsTLI Tissue Level Precision ImplantTLI Healing Caps Abutments in 3.5, 4.5, 5.5mm HeightTLI Overdenture Liberator Abutment in 2, 3, 4 and 5mm LengthsTLI Titanium Coping Abutments in 11mm Bridge, 11 Crown, 4.5mm Bridge, 4.5mm Crown | 2015 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment, Implant, Dental EndosseousAccelx cover screwsAccelx dental implantsBar Retained Abutments, Multi-Unit Bar Retained Abutments, Screw Retained Abutment, Cover Screw, Healing CapCC Cement Retained AbutmentsCC Cover ScrewCC Healing CapsCC Liberator Overdenture AbutmentsCC Prosthetic ScrewCC Screw-Retained Abutments (Single-unit Abutments and Multi-Unit Abutments) 18 moreCC SRA Healing AbutmentsCC SRA Titanium Coping AbutmentsCC Temporary PEEK AbutmentsCC Temporary Titanium AbutmentsLaser Marked Titanium AbutmentsMilled Abutment, Straight MU Abutment, Liberator AbutmentMPC, APC, UPC, CPC ImplantsMPI 6mm, MPI OD3.3mm, ULT, APIMPI, CPI, OPIRecover Cover Screw (NP & RP), Rapid Cover Screw (NP & RP)Reflect Recover Implant (NP & RP), Reflect Rapid Implant (NP & RP)Straight Abutment, Anatomic Angulated Abutment, Angulated Abutments, Ball Retained Abutments, Temporary AbutmentsTiN Coated Overdenture AbutmentsTiN Coated TLI Liberator and TLI Overdenture AbutmentsTLI Tissue Level Precision ImplantTLI Healing Caps Abutments in 3.5, 4.5, 5.5mm HeightTLI Overdenture Liberator Abutment in 2, 3, 4 and 5mm LengthsTLI Titanium Coping Abutments in 11mm Bridge, 11 Crown, 4.5mm Bridge, 4.5mm Crown | 2015 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Casting Abutment, Guided Anchoring Screw, Guided Fixation Pin, Guided Insertion Mount, Guided Sleeve,Countersink - Standard platform OD 3.75 / 4.2mm, Countersink - wide platform OD 5 / 6mm,Depth Probe, Long hand and ratchet insertion tool, Short hand & ratchet insertion tool, Long Hand key 1.25 mm,Drill extender Marking drill 1.9mm, Pilot drill 2mm, Twist Drill 2.5mm, Twist Drill 2.8mm, Twist Drill 3.2 mm,Impression Coping Transfer, Impression Coping Analog, Insertion Drivers, Multi-Unit Driver,Overdenture Processing Components, Prosthetic Screwdrivers, Tool Extractor.Parallel pin, Long ratchet key 1.25mm, Short ratchet key 1.25mm, Ratchet wrench, Ratchet torque Straight multiunit keyReflect Rapid Ratchet Connector Assembly, Long and ShortShort Hand key 1.25 mm, Long Motor insertion tool, Long Motor Adaptor, Short Motor Insertion tool, Short Motor Adaptor,Short Twist Drill 2.5 / 2.8 / 3.2 / 3.8 / 4.5 / 5 / 5.5 mm, Guided Step Drill, Milling Drill, Tissue Punch, 2 moreTrephine Drill, Stopper Twist Drill.Twist Drill 3.8 mm, Twist Drill 4.5 mm, Twist Drill 5 mm, Twist Drill 5.5 mm, Short Pilot drill 2 mm, | 2017 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Surgical TraySurgical Kit full, Mini Surgical Kit, Stainless Steel Surgical Tube, Integral Stopper Kit | 2017 |
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
Ditron Dental 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: Ditron Precision, Ltd. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Oct 2016 | K161497 | Dental Implants and Abutments | Ditron Precision, Ltd. | DZE Root-Form Endosseous Implant |
| 17 Oct 2014 | K140728 | MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR | Ditron Precision, Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DITRON DENTAL LTDFDA reg. 3010948854 | Ashkelon Southern, Israel | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049877). 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.