Manufacturer registered with FDA
Dfl Industria E Comercio SA
Rio de Janeiro, Brazil. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 7
- 510(k) clearances
- 22013–2013
- Markets registered in
- 6194 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Dfl Industria E Comercio SA 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 | Dfl Industria E Comercio SA | 2 clearances | 2013–2013 | Below |
| Colombia | INVIMA | Registration holder | DFL INDUSTRIA E COMERCIO S/ADFL INDUSTRIA E COMERCIO SA | 132 | — | Pure Global AI |
| Brazil | ANVISA | Registration holder | DFL INDÚSTRIA E COMÉRCIO S/A | 58 | 1996–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DFL Indústria e Comércio S/A | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DFL INDÚSTRIA E COMÉRCIO S/A | 1 | 2022–2022 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DFL INDUSTRIA E COMERCIO LTDA | 1 | 2004–2004 | 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 Dfl Industria E Comercio SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | Vitro Fil LCVitro Molar | 2013 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | DencojetUnoject | 2020 |
| Shellac Base PlateEEA · Class 1 | — | Lister | Placa base | 2020 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | KS Dent | 2020 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Steel Strips | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DFL INDUSTRIA E COMERCIO SAFDA reg. 3005308868 | Rio de Janeiro, Brazil | Contract manufacturer, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039286). 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.