Data / Medical devices / Brazil / 3R Industria E Comercio Ltda
3R Industria E Comercio Ltda: FDA-registered device maker in Sao Paulo, Brazil, 1 510(k) clearance
3R Industria E Comercio Ltda is registered with the FDA (registration 3002820615) in Sao Paulo, Brazil. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002820615
- Address
- Rua Ptolomeu, 290 Vila Socorro, Sao Paulo, Brazil, 04762-040
- Owner or operator
- 3R INDUSTRIA E COMERCIO LTDA (9052649)
- Roles
- Manufacturer
- First device listed
- August 10, 2005
- Registered through
- 2026
- Brand names listed
- Accessory, Surgical Apparel - Face Shield, Bur, Dental - MICRODONT; MICRODONT DENTAL CARBIDE BURS, Disk, Rubber Cup and Cone for Dentistry - Polishing and Finishing, ForceFlex Rotary File 7 4 #17 21MM, C/6, ForceFlex Rotary File 7 4 #17 25MM, C/6, ForceFlex Rotary File 7 4 #17 29MM, C/6, ForceFlex Rotary File 7 4 #20 21MM, C/6, ForceFlex Rotary File 7 4 #20 25MM, C/6 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Matrix | JEP | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 16, 1993 | K923757 | DENTAL DIAMOND DRILLS | DZP | Substantially Equivalent | Alpha Industrializacao DE Metais Ltda. | accessdata.fda.gov |
Compare with other makers
- All makers of File, Pulp Canal, Endodontic
- All makers of Instrument, Diamond, Dental
- All makers of Accessory, Surgical Apparel
- All makers of Disk, Abrasive
- All makers of Retainer, Matrix
- All makers of Bur, Dental
Updated March 16, 1993. 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.