Manufacturer registered with FDA
Polident d.o.o.
VOLCJA DRAGA, Slovenia. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 10
- 510(k) clearances
- 22012–2016
- Markets registered in
- 857 registrations outside the US
- Establishments
- 1Slovenia
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Polident d.o.o. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Polident d.o.o. | 2 clearances | 2012–2016 | Below |
| Serbia | ALIMS | Manufacturer | PoliDent d.o.o. | 20 | 2023–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | POLIDENT d.o.o | 14 | — | Pure Global AI |
| Australia | TGA | Manufacturer | PoliDent doo | 9 | 2013–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Polident D.O.O. | 6 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | POLIDENT D.O.O. | 5 | 2016–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | POLIDENT D.O.O. | 2 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Polident d.o.o. | 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 Polident d.o.o. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | DD poly Y MLPink CAD/CAM DiscPMMA CAD/CAM disc | 2012 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Artificial teeth CROSS LINKED 2Artificial teeth ICX-ROYALArtificial teeth REF-LINEDD poly Y MLPMMA CAD/CAM discPRIMODENT ACRYLIC TEETH | 2005 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Pink CAD/CAM Disc | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Polident d.o.o. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Sep 2016 | K153546 | PINK CAD/CAM disc | EBI Rebasing Repairing Relining Denture Resin |
| 28 Aug 2012 | K112967 | PMMA CAD/CAM DISC | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Dental Direkt GmbH (1).
Also lists devices cleared under other names
Polident d.o.o. 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: I.T.C. Ent. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Feb 1994 | K926070 | PRIMODENT ACRYLIC TEETH | I.T.C. Ent. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| POLIDENT d.o.o., Dental products industryFDA reg. 1000243214 | VOLCJA DRAGA Rence-Vogrsko, Slovenia | Manufacturer |
Other names on FDA records
Polident D.O.O., Dental Products Industry
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9021465). 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.