Data / Medical devices / Brazil / D.S.P. Industrial Eireli Epp
D.S.P. Industrial Eireli Epp: FDA-registered device maker in Campo Largo Parana, Brazil, 1 510(k) clearance
D.S.P. Industrial Eireli Epp is registered with the FDA (registration 3018662547) in Campo Largo Parana, Brazil. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 11, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018662547
- Address
- Streat Marechal Floriano Peixoto 303, Ouro Verde II Brazil, Campo Largo Parana, Brazil, 83606290
- Owner or operator
- D.S.P. Industrial EIRELI EPP (10082658)
- Roles
- Manufacturer
- First device listed
- September 2, 2021
- Registered through
- 2026
- Brand names listed
- ANGLED HE COUNTERSINK DRILL, ANGLED HE DRILLS, ANGLED HE INITIAL DRILL, Academic Prosthetic Kit Case, CMI Instruments, CONICAL BONE DENSIFIERS, CONICAL DRILL TO STOP, CONICAL DRILLS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 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 |
|---|---|---|---|---|---|---|
| February 11, 2021 | K192839 | DSP Implant System | DZE | Substantially Equivalent | D.S.P Industrial Eireli | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Post, Root Canal
Updated February 11, 2021. 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.