Data / Medical devices / Brazil / Olsen Industria E Comercio S/A
Olsen Industria E Comercio S/A: FDA-registered device maker in Palhoca Santa Catarina, Brazil, 2 510(k) clearances
Olsen Industria E Comercio S/A is registered with the FDA (registration 3003548115) in Palhoca Santa Catarina, Brazil. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 19, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003548115
- Address
- Avenida Ivo Lucchi, 68 Jardim Eldorado, Palhoca Santa Catarina, Brazil, 88133-510
- Owner or operator
- OLSEN INDUSTRIA E COMERCIO S/A (10042326)
- Roles
- Manufacturer
- First device listed
- November 14, 2012
- Registered through
- 2026
- Brand names listed
- CHAIR, DENTAL, WITHOUT OPERATIVE UNIT, Chair, surgical, ac-powered, Controller, foot, handpiece and cordUnit, operative dental, LIGHT, OPERATING, DENTAL, TABLE, EXAMINATION, MEDICAL, POWERED, TABLE, POWERED, Unit, operative dental
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Surgical, Ac-Powered | GBB | 1 | Manufacturer | accessdata.fda.gov |
| Controller, Foot, Handpiece And Cord | EBW | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Table, Examination, Medical, Powered | LGX | 1 | Manufacturer | accessdata.fda.gov |
| Table, Powered | INQ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 19, 2022 | K213742 | Infinity Pro, Logic, Quality, Sprint | EIA | Substantially Equivalent | Olsen Indústria E Comércio S.A. | accessdata.fda.gov |
| February 5, 2020 | K180935 | Infinity / Infinity Cross Flex Dental Systems | EIA | Substantially Equivalent | Olsen Industria E Comercio S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Dental, Without Operative Unit
- All makers of Light, Operating, Dental
- All makers of Table, Examination, Medical, Powered
- All makers of Controller, Foot, Handpiece And Cord
- All makers of Unit, Operative Dental
- All makers of Table, Powered
Updated October 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.