Manufacturer registered with FDA
Materialise NV
Leuven, Belgium. Lists 2 dental device types with FDA across 5 registered establishments, and holds 5 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 14
- 510(k) clearances
- 52011–2026
- Markets registered in
- 13244 registrations outside the US
- Establishments
- 5Belgium, Colombia, Malaysia +2
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Materialise NV 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 | Materialise NV | 5 clearances | 2011–2026 | Below |
| Canada | Health Canada | Registration holder | MATERIALISE N.V. | 120 | 2005–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Materialise NV | 51 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Materialise NV | 18 | 2012–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Materialise N.V.Materialise NV | 17 | 2010–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Materialise NV | 10 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MATERIALISE NVMaterialise N.V. · Materialise NV · +1 | 7 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MATERIALISE NVMaterialise NV | 5 | 2020–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MATERIALISE NVMATERIALISE USA, LLC | 5 | 2010–2025 | Pure Global AI |
| Malaysia | MDA | Registration holder | MATERIALISE SDN BHD | 4 | 2023–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Materialise NV | 4 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ｍａｔｅｒｉａｌｉｓｅ Ｎ．Ｖ． | 2 | 2014–2015 | Pure Global AI |
| China | NMPA | Registration holder | 比利时玛特瑞尔莱斯有限公司Materialise N.V. | 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 Materialise NV currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | ProPlan CMF GuidesSurgiCase CMF GuidesTruMatch CMF Ti 3D-Printed ImplantsTruMatch CMF Ti 3D-Printed PlatesTruMatch CMF Ti 3D-Printed Surgical GuidesTruMatch CMF Titanium 3D Printed Implant System | 2011 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | CMF Plastic ModelsCMF Titanium GuidesMaterialise Mimics Enlight CMFMaterialise Personalized Guides and Models for Craniomaxillofacial SurgeryMimics Enlight CMFProPlan CMF ModelsTRUMATCH CMF Titanium 3D Printed GuidesTruMatch CMF Titanium 3D Printed Splints | 2024 |
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 Materialise NV as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Oct 2026 | K260913 | CMF Titanium Splints | DZJ Manual Wire Driver and Bone Drill |
| 21 Feb 2025 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | DZJ Manual Wire Driver and Bone Drill |
| 10 Jul 2018 | K173039 | TruMatch CMF Titanium 3D Printed Implant | JEY Bone Plate |
| 8 Aug 2017 | K170272 | TruMatch CMF Titanium 3D Printed Implant System | JEY Bone Plate |
| 18 Mar 2011 | K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Materialise Colombia S.A.SFDA reg. 3011724582 | Medellin Antioquia, Colombia | Manufacturer |
| MATERIALISE N.V.FDA reg. 3003998208 | LEUVEN Vlaams Brabant, Belgium | Manufacturer |
| Materialise Sdn BhdFDA reg. 3009555447 | Petaling Jaya Selangor, Malaysia | Manufacturer |
| Materialise Ukraine, Rep. officeFDA reg. 3009555440 | Kyiv Kyyiv, Misto, Ukraine | Manufacturer |
| Materialise USA, LLC.FDA reg. 3005718816 | Plymouth, MI, United States | Manufacturer |
Other names on FDA records
Materialise Usa, LLC · Materialise Colombia S.A.S · Materialise Ukraine, Rep. office
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9029485). 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.