Data / Medical devices / Slovenia / POLIDENT d.o.o., Dental products industry
POLIDENT d.o.o., Dental products industry: FDA-registered device maker in VOLCJA DRAGA Rence-Vogrsko, Slovenia, 3 510(k) clearances
POLIDENT d.o.o., Dental products industry is registered with the FDA (registration 1000243214) in VOLCJA DRAGA Rence-Vogrsko, Slovenia. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 28, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000243214
- Address
- Volcja Draga 42, VOLCJA DRAGA Rence-Vogrsko, Slovenia, 5293
- Owner or operator
- Polident d.o.o. (9021465)
- Roles
- Manufacturer
- First device listed
- August 3, 2005
- Registered through
- 2026
- Brand names listed
- Artificial teeth CROSS LINKED 2, Artificial teeth ICX-ROYAL, Artificial teeth REF-LINE, DD poly Y ML, PMMA CAD/CAM disc, PRIMODENT ACRYLIC TEETH, Pink CAD/CAM Disc
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | 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 |
|---|---|---|---|---|---|---|
| September 28, 2016 | K153546 | PINK CAD/CAM disc | EBI | Substantially Equivalent | Polident D.O.O., Dental Products Industry | accessdata.fda.gov |
| August 28, 2012 | K112967 | PMMA CAD/CAM DISC | EBG | Substantially Equivalent | Polident D.O.O., Dental Products Industry | accessdata.fda.gov |
| February 17, 1994 | K926070 | PRIMODENT ACRYLIC TEETH | ELM | Substantially Equivalent | I.T.C. Ent. | accessdata.fda.gov |
Compare with other makers
- All makers of Denture, Plastic, Teeth
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated September 28, 2016. 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.