Data / Medical devices / Brazil / Dentsply Industria E Comercio Ltda
Dentsply Industria E Comercio Ltda: FDA-registered device maker in PIRASSUNUNGA Sao Paulo, Brazil, 1 510(k) clearance
Dentsply Industria E Comercio Ltda is registered with the FDA (registration 3003756493) in PIRASSUNUNGA Sao Paulo, Brazil. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003756493
- Address
- Rua Carlos Tassoni 4521, Galpao 01 Distrito Industrial, PIRASSUNUNGA Sao Paulo, Brazil, 13633-418
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 16, 2008
- Registered through
- 2026
- Brand names listed
- Multilayer PMMA, PMMA Disks, Shaded PMMA, VIPI BLOCK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| December 16, 2010 | K102341 | VIPI BLOCK | EBG | Substantially Equivalent | Vipi Industria,Comercio,Exportacao E Importacao DE | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated December 16, 2010. 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.