Manufacturer registered with FDA
ITM Industria de Tecnologias Medicas LTDA
Canoas, Brazil. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 334 registrations outside the US
- Establishments
- 1Brazil
Registered in 3 markets
Where regulators' registries name ITM Industria de Tecnologias Medicas LTDA 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 | ITM Industria de Tecnologias Medicas LTDA | 3 device types | — | Below |
| Brazil | ANVISA | Registration holder | ITM INDUSTRIA DE TECNOLOGIAS MEDICAS LTDA. | 33 | 1996–2021 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ITM INDUSTRIA DE TECNOLOGIAS MEDICAS LTDA. | 1 | 2025–2025 | 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 ITM Industria de Tecnologias Medicas LTDA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Suction Operatory Unit | 1992 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractor | 1996 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Surgical Rongeur Forceps | 1992 |
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 |
|---|---|---|
| ITM Industria de Tecnologias Medicas LTDAFDA reg. 8043769 | CANOAS Rio Grande do Sul, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9003722). 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.