Manufacturer registered with FDA
Noris Medical Ltd.
Nesher, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 0
- 510(k) clearances
- 82014–2025
- Markets registered in
- 10822 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Noris Medical 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 | Noris Medical Ltd. | 8 clearances | 2014–2025 | Below |
| European Union | EUDAMED | Manufacturer | NORIS MEDICAL LtdNoris Medical GmbH | 492 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | NORIS MEDICAL LTD. | 270 | 2018–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Noris Medical GmbhNoris Medical Ltd | 21 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Noris Medical Ltd. | 14 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NORIS MEDICAL LTD. | 9 | 2022–2025 | Pure Global AI |
| India | CDSCO | Registration holder | Noris Medical Private LimitedNORIS MEDICAL PVT.LTD. | 9 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Noris Medical Ltd | 3 | 2022–2023 | Pure Global AI |
| Colombia | INVIMA | Registration holder | NORIS MEDICAL LTD | 3 | — | Pure Global AI |
| China | NMPA | Registration holder | 诺利齿医学公司Noris Medical 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 Noris Medical 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 | — | 2015 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2015 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2015 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2015 |
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 Noris Medical Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Feb 2025 | K241462 | LONGY Implant and LONGY-N Implant | DZE Root-Form Endosseous Implant |
| 6 Jun 2024 | K240202 | Conical Platform Dental Implants System | DZE Root-Form Endosseous Implant |
| 24 Jun 2022 | K210852 | Noris Medical Dental Implants System - Cortical | DZE Root-Form Endosseous Implant |
| 4 Feb 2022 | K210356 | Noris Medical Dental Implants System | NHA Endosseous Dental Implant Abutment |
| 17 Mar 2017 | K162308 | Noris Medical MBI-2mm Dental Implant System | DZE Root-Form Endosseous Implant |
| 11 Apr 2016 | K153043 | Noris Medical MBI Dental Implant System | DZE Root-Form Endosseous Implant |
| 8 Apr 2016 | K151909 | Noris Medical Zygomatic Dental Implant System | DZE Root-Form Endosseous Implant |
| 19 Dec 2014 | K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NORIS MEDICAL LTD.FDA reg. 3011390931 | Nesher Haifa, Israel | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048677). 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.