Manufacturer registered with FDA
Olsen Indústria E Comércio S.A.
Palhoca, Brazil. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 6
- 510(k) clearances
- 22020–2022
- Markets registered in
- 516 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Olsen Indústria E Comércio 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 | Olsen Indústria E Comércio S.A. | 2 clearances | 2020–2022 | Below |
| Brazil | ANVISA | Registration holder | OLSEN INDUSTRIA E COMÉRCIO S/A | 12 | 2004–2016 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OLSEN INDUSTRIA E COMERCIOOLSEN INDUSTRIA E COMÉRCIO S/A | 2 | 2011–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Olsen Industria e Comercio SA | 1 | 2024–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Olsen Industria E Comércio S/A | 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 Olsen Indústria E Comércio 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 |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Controller, foot, handpiece and cordUnit, operative dentalUnit, operative dental | 2020 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Controller, foot, handpiece and cordUnit, operative dentalUnit, operative dental | 2020 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | LIGHT, OPERATING, DENTAL | 2022 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT | 2021 |
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 |
|---|---|---|
| OLSEN INDUSTRIA E COMERCIO S/AFDA reg. 3003548115 | Palhoca Santa Catarina, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042326). 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.