Manufacturer registered with FDA
Evoden Industria Comercio Importacao e Exportacao de Produto
Pirassununga, Brazil. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 315 registrations outside the US
- Establishments
- 1Brazil
Registered in 3 markets
Where regulators' registries name Evoden Industria Comercio Importacao e Exportacao de Produto 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 | Evoden Industria Comercio Importacao e Exportacao de Produto | 4 device types | — | Below |
| Brazil | ANVISA | Manufacturer | EVODEN INDUSTRIA, COMERCIO, IMPORTACAO E EXPORTACAO DE PRODUTOS ODONTOLOGICOS LTDA | 14 | 2022–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | EVODEN INDÚSTRIA, COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS ODONTOLÓGICOS LTDA | 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 Evoden Industria Comercio Importacao e Exportacao de Produto currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Denture Hydrophilic CoatingEBE · Class 2 | — | Maker | EvoflexEvolut HIREvopackEvopourTermoden | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | EvoblockPerleon | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | EvoblockPerleon | 2025 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | DuodentDuolutEcodentEvodentEvolutEvotri | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Evoden Industria Comercio Importacao e Exportacao de Produto lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Evoden Indústria Comércio Importação E Exportação (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Apr 2025 | K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EVODEN INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE PRODUTOS ODONTOLOGICOS LTDA.FDA reg. 3023346365 | Pirassununga Sao Paulo, Brazil | Manufacturer |
Other names on FDA records
Evoden Indústria, Comércio, Importação E Exportação de Produtos Odontológicos Ltda
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086171). 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.