Data / Medical devices / Brazil / Vigodent Industria E Comercio Ltda
Vigodent Industria E Comercio Ltda: FDA-registered device maker in Rio de Janeiro, Brazil, 1 510(k) clearance
Vigodent Industria E Comercio Ltda is registered with the FDA (registration 3002785217) in Rio de Janeiro, Brazil. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002785217
- Address
- Rua Pesqueira, 26, Rio de Janeiro, Brazil, 21041-150
- Owner or operator
- Vigodent Industria e Comercio Ltda (10088914)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 20, 2023
- Registered through
- 2026
- Brand names listed
- Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print, Magic White, Magic White Office, Pasta Herjos F, Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular, Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121);, Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer, Specification developer | 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 31, 2025 | K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | ELW | Substantially Equivalent | Vigodent Indústria E Comercio Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Eraser, Dental Stain
- All makers of Material, Impression
Updated October 31, 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.