Manufacturer registered with FDA
ADIN DENTAL IMPLANT SYSTEMS Ltd
Alon Tavor, Israel. Lists 9 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 189
- 510(k) clearances
- 32023–2026
- Markets registered in
- 10498 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name ADIN DENTAL IMPLANT SYSTEMS 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 | ADIN DENTAL IMPLANT SYSTEMS Ltd | 3 clearances | 2023–2026 | Below |
| Canada | Health Canada | Registration holder | ADIN DENTAL IMPLANT SYSTEMS LTD. | 273 | 2010–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Adin Dental Implant Systems LTD. | 122 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Adin Dental Implant Systems Ltd | 35 | 2014–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Adin Dental Implant Systems Ltd. | 27 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Adin Dental Implant Systems Ltd | 25 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ADIN DENTAL IMPLANT SYSTEMS LTD | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ADIN DENTAL IMPLANT SYSTEMS LTD. | 5 | 2012–2021 | Pure Global AI |
| China | NMPA | Registration holder | 雅定种植系统有限公司ADIN DENTAL IMPLANT SYSTEMS LTD雅定种植系统有限公司ADIN DENTAL IMPLANT SYSTEMS LTD. · 雅定种植系统有限公司Adin Dental Implant Systems Ltd. | 4 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Adin Dental Implant Systems Ltd. | 1 | 2012–2012 | 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 ADIN DENTAL IMPLANT SYSTEMS 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Adin Dental Implants SystemAdin Short ImplantsADIN UNIFIT DENTAL IMPLANT SYSTEMAnatomic AbutmentsC-Type Ti BaseCement retained abutments for NP (straight, angled 15deg, angled 25deg, temporary)Cement retained abutments for RP and WP (straight, straight slim, angled 15deg, temporary)Cement retained abutments for RS dental implants (straight, slim straight, angled 15, angled 25, esthetic angled 15)Cement retained abutments for RS implants (straight cylindrical, one piece screw-in, wide profile, slim 3mm, angled longCement retained abutments for UNP (straight, straight slim, angled 15deg, temporary, one piece screw-in) 64 moreFlat Connection system for RS implants (abutments, temporary sleeve, gluing ring, retaining screw)Gold / Plastic abutments for NP (engaging and non-engaging)Healing abutments for NP (regular 4.5mmD, slim 3mmD, conical 4.5mmD)Healing Abutments for RP and WP implants (regular, slim, conical)Healing abutments for RS implants (Wide 6mmD, Slim 3.5mmD)Healing abutments for UNP (regular 4mmD, slim 2.75mmD, conical 4mmD)IRIS, NP PlatformIRIS, NP Snap-on Impression KitIRIS, RS PlatformIRIS, UNP PlatformIRIS, UNP Snap-on Impression KitIRIS", RP PlatformIRIS", RP Snap-on Impression KitIRIS", WP PlatformIRIS", WP Snap-on Impression KitNP and TMA Grip AbutmentsOverdenture abutments (RS Ball Attachments 0.5-5mm, plastic ball caps, titanium ball cap, SS ball cap)Overdenture abutments for NP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm)Overdenture abutments for RP and WP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm)Overdenture abutments for RS implants (cylindrical grip 2-6mm)Overdenture abutments for UNP (Ball attachments 0.5-5mm)Retaining screws for NP TMA abutments (straight and angled)Retaining screws for RP and WP TMA abutments (straight and angled)Retaining screws for TMA abutments (straight and angled)RS Angled Trans Mucosal Abutment 45-60°RS Grip Abutments and accessoriesRS Healing Abutments 3.5-6mmD 6-7mmLRS Healing Abutments 4.5mmD 2-6mmLScrew retained abutments (RS straight single TMA 1-5mm, RS Angled single TMA 17° 2-3mm, RS Angled single TMA 30° 3-4mm)Screw retained abutments for NP (Flat connection abutment 2, 4mm)Screw retained abutments for NP (straight single TMA 1-5mm, Angled single TMA 17° 3-4mm, Angled single TMA 30° 3.5-5mm)Screw retained abutments for NP (Straight TMA 1-5mm, angled 17deg and 30deg)Screw retained abutments for RP and WP (Flat connection abutment 2, 4mm)Screw retained abutments for RP and WP (Straight TMA 1-5mm, angled 17deg and 30deg)Screw retained abutments for RP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm)Screw retained abutments for RS dental implants (connection abutments, esthetic connection abutments)Screw retained abutments for RS dental implants (straight TMA 1-5mm, Angled TMA 17° 2-3mm, Angled TMA 30° 3-4mm)Screw retained abutments for UniFit dental implants (straight TMA 1-5mm, angled TMA 17-30 deg 2.5-4mm)Screw retained abutments for WP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm)Single TMA Cementing ConeSwell, Touareg (Touareg-X), Touareg-S ImplantsSwell, Touareg-S, Touareg-OS dental implants in 18mmLTi Bases for Touareg CloseFit NP dental implants (Engaged, Non-Engaged, Angular Engaged), NP C-Type Ti BaseTi Bases for Touareg CloseFit UNP dental implants (Engaged, Non-Engaged, Angular Engaged), UNP C-Type Ti BaseTitanium / Plastic abutments for RP and WP (engaging and non-engaging)Titanium / Plastic abutments for RS implants (engaging and non-engaging)TMA Cementing ConeTMA components (TMA healing cap, TMA titanium temporary copying)Touareg CloseFit RP and WP Ti Bases (Engaged, Non-Engaged, Angular Engaged), RP and WP C-Type Ti baseTOUAREG CloseFit UNP 2.75mmD implantsTouareg OS Dental ImplantTouareg OS Zygomatic Dental ImplantTouareg UniFit Dental Implants ( 3.5-6mmD 6-18mmL)Touareg-S / OS implants in 3.5mmD and 8mmLUniFit Cement retained abutments (straight, angled 15, angled 25)UniFit Flat Connection Abutments (2mm, 4mm)UniFit Healing Abutment 3.5-5.5mmD 2-6mmLUniFit Overdenture abutments (Ball Attachments 0.5-5mm, Grip abutments 1-6mm)UniFit Retaining screws for TMA abutments (straight and angled)UniFit Straight Single TMA (Straight 1-5mm, Angled 17°-30°)UniFit Ti Bases (Engaged, Non-Engaged, Angular Engaged), UniFit C-Type Ti BaseUniFit Ti Pre Milled MDTK Abutment BlankUNP CloseFit Ti Pre Milled MDTK Abutment BlankWP and RP Touareg CloseFit Dental Implants | 2009 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Adin Dental Implants SystemADIN UNIFIT DENTAL IMPLANT SYSTEMAnatomic AbutmentsC-Type Ti BaseCement retained abutments for NP (straight, angled 15deg, angled 25deg, temporary)Cement retained abutments for RP and WP (straight, straight slim, angled 15deg, temporary)Cement retained abutments for RS dental implants (straight, slim straight, angled 15, angled 25, esthetic angled 15)Cement retained abutments for RS implants (straight cylindrical, one piece screw-in, wide profile, slim 3mm, angled longCement retained abutments for UNP (straight, straight slim, angled 15deg, temporary, one piece screw-in)Flat Connection system for RS implants (abutments, temporary sleeve, gluing ring, retaining screw) 69 moreGold / Plastic abutments for NP (engaging and non-engaging)Healing abutments for NP (regular 4.5mmD, slim 3mmD, conical 4.5mmD)Healing Abutments for RP and WP implants (regular, slim, conical)Healing abutments for RS implants (Wide 6mmD, Slim 3.5mmD)Healing abutments for UNP (regular 4mmD, slim 2.75mmD, conical 4mmD)IRIS, NP PlatformIRIS, NP Snap-on Impression KitIRIS, RS PlatformIRIS, UNP PlatformIRIS, UNP Snap-on Impression KitIRIS", RP PlatformIRIS", RP Snap-on Impression KitIRIS", WP PlatformIRIS", WP Snap-on Impression KitNP and TMA Grip AbutmentsNP CloseFit Ti Pre Milled MDTK Abutment BlankOverdenture abutments (RS Ball Attachments 0.5-5mm, plastic ball caps, titanium ball cap, SS ball cap)Overdenture abutments for NP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm)Overdenture abutments for RP and WP (Ball attachments 0.5-5mm, cylindrical grip 2-6mm)Overdenture abutments for RS implants (cylindrical grip 2-6mm)Overdenture abutments for UNP (Ball attachments 0.5-5mm)Retaining screws for NP TMA abutments (straight and angled)Retaining screws for RP and WP TMA abutments (straight and angled)Retaining screws for TMA abutments (straight and angled)RP CloseFit Ti Pre Milled MDTK Abutment BlankRS Angled Trans Mucosal Abutment 45-60°RS CloseFit Ti Pre Milled MDTK Abutment BlankRS Grip Abutments and accessoriesRS Healing Abutments 3.5-6mmD 6-7mmLRS Healing Abutments 4.5mmD 2-6mmLScrew retained abutments (RS straight single TMA 1-5mm, RS Angled single TMA 17° 2-3mm, RS Angled single TMA 30° 3-4mm)Screw retained abutments for NP (Flat connection abutment 2, 4mm)Screw retained abutments for NP (straight single TMA 1-5mm, Angled single TMA 17° 3-4mm, Angled single TMA 30° 3.5-5mm)Screw retained abutments for NP (Straight TMA 1-5mm, angled 17deg and 30deg)Screw retained abutments for RP and WP (Flat connection abutment 2, 4mm)Screw retained abutments for RP and WP (Straight TMA 1-5mm, angled 17deg and 30deg)Screw retained abutments for RP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm)Screw retained abutments for RS dental implants (connection abutments, esthetic connection abutments)Screw retained abutments for RS dental implants (straight TMA 1-5mm, Angled TMA 17° 2-3mm, Angled TMA 30° 3-4mm)Screw retained abutments for UniFit dental implants (straight TMA 1-5mm, angled TMA 17-30 deg 2.5-4mm)Screw retained abutments for WP(straight single TMA 1-5mm, Angled single TMA 17° 2.5-3.5mm, Angled single TMA 30° 3-4mm)Single TMA Cementing ConeSwell, Touareg (Touareg-X), Touareg-S ImplantsSwell, Touareg-S, Touareg-OS dental implants in 18mmLTi Base RS AbutmentTi Base UniFit AbutmentTi Bases for Touareg CloseFit NP dental implants (Engaged, Non-Engaged, Angular Engaged), NP C-Type Ti BaseTi Bases for Touareg CloseFit UNP dental implants (Engaged, Non-Engaged, Angular Engaged), UNP C-Type Ti BaseTitanium / Plastic abutments for RP and WP (engaging and non-engaging)Titanium / Plastic abutments for RS implants (engaging and non-engaging)TMA Cementing ConeTMA components (TMA healing cap, TMA titanium temporary copying)Touareg CloseFit RP and WP Ti Bases (Engaged, Non-Engaged, Angular Engaged), RP and WP C-Type Ti baseTOUAREG CloseFit UNP 2.75mmD implantsTouareg OS Dental ImplantTouareg OS Zygomatic Dental ImplantTouareg UniFit Dental Implants ( 3.5-6mmD 6-18mmL)Touareg-S / OS implants in 3.5mmD and 8mmLUniFit Cement retained abutments (straight, angled 15, angled 25)UniFit Flat Connection Abutments (2mm, 4mm)UniFit Healing Abutment 3.5-5.5mmD 2-6mmLUniFit Overdenture abutments (Ball Attachments 0.5-5mm, Grip abutments 1-6mm)UniFit Retaining screws for TMA abutments (straight and angled)UniFit Straight Single TMA (Straight 1-5mm, Angled 17°-30°)UniFit Ti Bases (Engaged, Non-Engaged, Angular Engaged), UniFit C-Type Ti BaseUniFit Ti Pre Milled MDTK Abutment BlankUNP CloseFit Ti Pre Milled MDTK Abutment BlankWP and RP Touareg CloseFit Dental ImplantsWP CloseFit Ti Pre Milled MDTK Abutment Blank | 2009 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Prosthetic Kit Metal, Prosthetic kit tray | 2014 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | x-cube | 2015 |
| All Precision AttachmentEGG · Class 1 | — | Maker | — | 2011 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Guided Surgery CloseFit Drills & Accessories KitGuided Surgery Drills 18mmGuided Surgery Drills, GS Pilot Drills, Anchoring DrillsTip Drill | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Angled Trans Mucosal Abutment GaugeDigital Analogs and ReplicasDrill stoppers. handles, hex tools, core tools, hex sample, centering ring, implant carrier, handlesGuided surgery anchorage screwGuided Surgery Anchorage Screws, SleevesGuided Surgery CloseFit Accessories KitGuided Surgery CloseFit ToolsGuided surgery tools, fixture mounts, sockets, ratchet, extraction tool. screw drivers, depth probe, tissue punchesIRIS - Snap OnOpen Tray Transfers, Close Tray Transfers, Screws for Transfers, Analogs, Replicas, Plastic Abutments, Casting Sleeve 2 moreScan Bodies (7mm,, 10mm). TMA Scan Bodies (6mm, 9mm), TMA Scan body ScrewSurgical Drivers, Angulated Drivers, Adapters, Parallel Pins, Depth Probe, Osteotome, Drill Extension, Ratchets, Wrench | 2011 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Maker | Adin Drill Stop Kits (Regular Long, Regular Short, Wide Long. Wide Short)Adin Tri Step Drill Stop KitCloseFit Metal Surgical Box (Small, Big)Guided Surgery Accessories Kit - UniFit ImplantsGuided Surgery Kits (Drills - Basic, Accessories - RS implants)Osteotome KitRS Internal Hex Plastic Surgical Kit (Premiu, Advanced, Starter)RS Metal Surgery Kit (Small, Big)UniFit - Standard Internal Star Plastic Surgical Kit (Advanced, Premium)UNP Starter Surgical Package 1 moreZygomatic surgical Kit, Standard Hex Tray | 2016 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | NP CloseFit Ti Pre Milled MDTK Abutment BlankRP CloseFit Ti Pre Milled MDTK Abutment BlankRS CloseFit Ti Pre Milled MDTK Abutment BlankTi Base RS AbutmentTi Base UniFit AbutmentUNP CloseFit Ti Pre Milled MDTK Abutment BlankWP CloseFit Ti Pre Milled MDTK Abutment Blank | 2025 |
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 ADIN DENTAL IMPLANT SYSTEMS Ltd as the applicant.
Also lists devices cleared under other names
ADIN DENTAL IMPLANT SYSTEMS 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: Adin Dental Implants Systems , Ltd. (3), Adin Dental Implants System, Ltd. (2), Saeshin Precision Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Jul 2022 | K212775 | Adin Short Implants | Adin Dental Implants Systems , Ltd. | DZE Root-Form Endosseous Implant |
| 6 May 2016 | K153111 | TOUAREG CloseFit UNP 2.75mmD | Adin Dental Implants Systems , Ltd. | DZE Root-Form Endosseous Implant |
| 31 Oct 2014 | K140293 | TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM | Adin Dental Implants Systems , Ltd. | DZE Root-Form Endosseous Implant |
| 24 May 2012 | K112585 | TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM | Adin Dental Implants System, Ltd. | DZE Root-Form Endosseous Implant |
| 21 Sep 2009 | K092758 | X-CUBE | Saeshin Precision Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 19 Dec 2008 | K081751 | ADIN DENTAL IMPLANTS SYSTEM | Adin Dental Implants System, Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ADIN DENTAL IMPLANT SYSTEMS LTD.FDA reg. 3007518363 | Afula Northern, Israel | Complaint file establishment, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028570). 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.