Manufacturer registered with FDA
NEOORTHO Produtos Ortopedicos S/A
Curitiba, Brazil. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 12010–2010
- Markets registered in
- 3131 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name NEOORTHO Produtos Ortopedicos S/A 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 | NEOORTHO Produtos Ortopedicos S/A | 1 clearances | 2010–2010 | Below |
| Brazil | ANVISA | Registration holder | NEOORTHO PRODUTOS ORTOPÉDICOS S/A | 118 | 2011–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NEOORTHO PRODUTOS ORTOPEDICOS S/ANEOORTHO PRODUTOS ORTOPÉDICOS S/A | 13 | 2019–2024 | 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 NEOORTHO Produtos Ortopedicos S/A 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 | CranioMaxillofacial Fixation (CMF) System - CMF VisionareMini and Micro Fragments Reconstruction System - NEOFACENeoorthoVisionare | 2011 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEOORTHO PRODUTOS ORTOPEDICOS S/AFDA reg. 3009158523 | Curitiba Parana, Brazil | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036684). 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.