Manufacturer registered with FDA
3R Industria e Comercio Ltda
SAO PAULO, Brazil. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 91
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12145 registrations outside the US
- Establishments
- 1Brazil
Registered in 12 markets
Where regulators' registries name 3R Industria e Comercio Ltda as the manufacturer or the registration holder of a device.
RegisteredHome: BrazilOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | 3R Industria e Comercio Ltda | 7 device types | — | Below |
| Brazil | ANVISA | Registration holder | 3 - R INDUSTRIA E COMERCIO LTDA3R Industria e Comércio Ltda | 88 | 2010–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | 3R INDUSTRIA E COMERCIO LTDA | 17 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | 3R Indústria E Comércio LTDA | 9 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | 3R Industria e Comercio Ltda.3R INDUSTRIA E COMERCIO LTDA | 7 | 2017–2022 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | 3R INDUSTRIA E COMERCIO LTDA.3R INDUSTRIA E COMERCIO LTD. | 6 | 2021–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | 3R Indústria e Comércio Ltda | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | 3R INDUSTRIA E COMERCIO LTDA | 4 | 2018–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | 3R Industria e Comercio Ltda | 3 | 2023–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | 3R INDUSTRIA E COMERCIO LTDA | 2 | 2023–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | 3R INDUSTRIA E COMÉRCIO LTDA | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | 3R Industria E Comercio 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 3R 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 |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Instrument, Diamond, Dental - HENRY SCHEIN - MICRODONT - DIAMOND BURS | 2005 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Disk, Rubber Cup and Cone for Dentistry - Polishing and Finishing | 2021 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Silicone Tips for Finishing and Polishing | 2021 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | MIR 1MIR 2MIR Prime 1Strip, Polishing Agent - MICRODONT - STRIP POLISHING AGENT | 2005 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Bur, Dental - MICRODONT; MICRODONT DENTAL CARBIDE BURSSoft Bur | 2005 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | ForceFlex Rotary File 7 4 #17 21MM, C/6ForceFlex Rotary File 7 4 #17 25MM, C/6ForceFlex Rotary File 7 4 #17 29MM, C/6ForceFlex Rotary File 7 4 #20 21MM, C/6ForceFlex Rotary File 7 4 #20 25MM, C/6ForceFlex Rotary File 7 4 #20 29MM, C/6ForceFlex Rotary File 7 4 #25 21MM, C/6ForceFlex Rotary File 7 4 #25 25MM, C/6ForceFlex Rotary File 7 4 #25 29MM, C/6ForceFlex Rotary File 7 4 #30 21MM, C/6 71 moreForceFlex Rotary File 7 4 #30 25MM, C/6ForceFlex Rotary File 7 4 #30 29MM, C/6ForceFlex Rotary File 7 4 #35 21MM, C/6ForceFlex Rotary File 7 4 #35 25MM, C/6ForceFlex Rotary File 7 4 #35 29MM, C/6ForceFlex Rotary File 7 4 #40 21MM, C/6ForceFlex Rotary File 7 4 #40 25MM, C/6ForceFlex Rotary File 7 4 #40 29MM, C/6ForceFlex Rotary File 7 4 #45 21MM, C/6ForceFlex Rotary File 7 4 #45 25MM, C/6ForceFlex Rotary File 7 4 #45 29MM, C/6ForceFlex Rotary File 7 6 #17 21MM, C/6ForceFlex Rotary File 7 6 #17 25MM, C/6ForceFlex Rotary File 7 6 #17 29MM, C/6ForceFlex Rotary File 7 6 #20 21MM, C/6ForceFlex Rotary File 7 6 #20 25MM, C/6ForceFlex Rotary File 7 6 #20 29MM, C/6ForceFlex Rotary File 7 6 #25 21MM, C/6ForceFlex Rotary File 7 6 #25 25MM, C/6ForceFlex Rotary File 7 6 #25 29MM, C/6ForceFlex Rotary File 7 6 #30 21MM, C/6ForceFlex Rotary File 7 6 #30 25MM, C/6ForceFlex Rotary File 7 6 #30 29MM, C/6ForceFlex Rotary File 7 6 #35 21MM, C/6ForceFlex Rotary File 7 6 #35 25MM, C/6ForceFlex Rotary File 7 6 #35 29MM, C/6ForceFlex Rotary File 7 6 #40 21MM, C/6ForceFlex Rotary File 7 6 #40 25MM, C/6ForceFlex Rotary File 7 6 #40 29MM, C/6ForceFlex Rotary File 7 6 #45 21MM, C/6ForceFlex Rotary File 7 6 #45 25MM, C/6ForceFlex Rotary File 7 6 #45 29MM, C/6Royalflex Rotary File. 04 #30 31MM, C/6Royalflex Rotary File. 06 #30 21MM, C/6Royalflex Rotary File4 #15 21MM, C/6Royalflex Rotary File4 #15 25MM, C/6Royalflex Rotary File4 #15 31MM, C/6Royalflex Rotary File4 #20 21MM, C/6Royalflex Rotary File4 #20 25MM, C/6Royalflex Rotary File4 #20 31MM, C/6Royalflex Rotary File4 #25 21MM, C/6Royalflex Rotary File4 #25 25MM, C/6Royalflex Rotary File4 #25 31MM, C/6Royalflex Rotary File4 #30 21MM, C/6Royalflex Rotary File4 #30 25MM, C/6Royalflex Rotary File4 #35 21MM, C/6Royalflex Rotary File4 #35 25MM, C/6Royalflex Rotary File4 #35 31MM, C/6Royalflex Rotary File4 #40 21MM, C/6Royalflex Rotary File4 #40 25MM, C/6Royalflex Rotary File4 #40 31MM, C/6Royalflex Rotary File4 #45 21MM, C/6Royalflex Rotary File4 #45 25MM, C/6Royalflex Rotary File4 #45 31MM, C/6Royalflex Rotary File4 #50 21MM, C/6Royalflex Rotary File4 #50 25MM, C/6Royalflex Rotary File4 #50 31MM, C/6Royalflex Rotary File6 #15 21MM, C/6Royalflex Rotary File6 #15 25MM, C/6Royalflex Rotary File6 #15 31MM, C/6Royalflex Rotary File6 #20 21MM, C/6Royalflex Rotary File6 #20 25MM, C/6Royalflex Rotary File6 #25 21MM, C/6Royalflex Rotary File6 #25 25MM, C/6Royalflex Rotary File6 #30 25MM, C/6Royalflex Rotary File6 #35 21MM, C/6Royalflex Rotary File6 #35 25MM, C/6Royalflex Rotary File6 #40 25MM, C/6Royalflex Rotary File6 #45 25MM ,C/6Royalflex Rotary File6 #50 21MM, C/6Royalflex Rotary File6 #50 25MM, C/6 | 2026 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Steel Matrix Band | 2021 |
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
3R Industria e Comercio Ltda 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: Alpha Industrializacao DE Metais Ltda. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Mar 1993 | K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | DZP Dental Diamond Instrument |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 3R INDUSTRIA E COMERCIO LTDAFDA reg. 3002820615 | SAO PAULO, Brazil | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052649). 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.