Noris Medical
Also known as: Noris Medical Dental Implant Solutions, Noris Medical Ltd.
An Israeli dental implant manufacturer based in Nesher, known for its Tuff implants and a broad range of zygomatic implants.
Key facts
| Country | IsraelVerified spec[1] |
|---|---|
| Headquarters | Nesher, IsraelManufacturer-reported[1] |
| Founded | Manufacturer documentation not located |
| Geographic availability | Product range spans Tuff, Tuff TT, Onyx, Cortical, Zygomatic and MBI implant linesManufacturer-reported[1] |
| manufacturingCountry | IsraelVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance7 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | 2025-02-11 |
| K240202 | Conical Platform Dental Implants System | Noris Medical , Ltd. | 2024-06-06 |
| K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical , Ltd. | 2022-06-24 |
| K162308 | Noris Medical MBI-2mm Dental Implant System | Noris Medical , Ltd. | 2017-03-17 |
| K153043 | Noris Medical MBI Dental Implant System | Noris Medical , Ltd. | 2016-04-11 |
| K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical , Ltd. | 2016-04-08 |
| K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | Noris Medical , Ltd. | 2014-12-19 |
Other2 records
Registered device establishment in Israel. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3011390931 | — | NORIS MEDICAL LTD. | — |
| 448 device records | — | Noris Medical | — |
Clearance records for Noris Medical were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Noris Medical.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Noris Medical — Dental Implant Solutions — Noris Medical Ltd.. Accessed 2026-07-22. (link was unreachable at last check)
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.