Data / Medical devices / Brazil / Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda.
Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda.: FDA-registered device maker in Pirassununga Sao Paulo, Brazil, 1 510(k) clearance
Evoden Industria Comercio Importacao E Exportacao De Produtos Odontologicos Ltda. is registered with the FDA (registration 3023346365) in Pirassununga Sao Paulo, Brazil. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023346365
- Address
- R: Genesio de Bem 1634 Distrito Industrial, Pirassununga Sao Paulo, Brazil, CEP 13633-
- Owner or operator
- Evoden Industria Comercio Importacao e Exportacao de Produto (10086171)
- Roles
- Manufacturer
- First device listed
- October 19, 2022
- Registered through
- 2026
- Brand names listed
- Duodent, Duolut, Ecodent, Evoblock, Evodent, Evoflex, Evolut, Evolut HIR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coating, Denture Hydrophilic, Resin | EBE | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | 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 |
|---|---|---|---|---|---|---|
| April 22, 2025 | K243621 | Evoblock, Perléon | EBG | Substantially Equivalent | Evoden Indústria Comércio Importação E Exportação | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Denture, Plastic, Teeth
- All makers of Coating, Denture Hydrophilic, Resin
Updated April 22, 2025. 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.