Manufacturer registered with FDA
Vigodent Industria e Comercio Ltda
Rio de Janeiro, Brazil. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 12025–2025
- Markets registered in
- 7163 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Vigodent Industria e Comercio Ltda 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 | Vigodent Industria e Comercio Ltda | 1 clearances | 2025–2025 | Below |
| Brazil | ANVISA | Registration holder | VIGODENT INDUSTRIA E COMERCIO LTDA. | 116 | 1999–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | VIGODENT INDUSTRIA E COMERCIO LTDA | 26 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | VIGODENT INDÚSTRIA E COMÉRCIO LTDA. | 15 | 2022–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Vigodent Indústria e Comércio LtdaVigodent Indústria E Comércio Ltda. | 4 | 2025–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Vigodent Indústria e Comercio LTDA. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Vigodent Indústria e Comércio 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 Vigodent Industria e Comercio Ltda currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Magic WhiteMagic White Office | 2023 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma PrintPerfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium RegularPremium 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); | 2026 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Pasta Herjos F | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Vigodent Industria e Comercio Ltda as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Oct 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 Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VIGODENT INDUSTRIA E COMERCIO LTDAFDA reg. 3002785217 | Rio de Janeiro, Brazil | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088914). 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.