Manufacturer registered with FDA
Verdent Ltd.
Lodz, Poland. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 55 registrations outside the US
- Establishments
- 1Poland
Registered in 5 markets
Where regulators' registries name Verdent Ltd. 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 | Verdent Ltd. | 7 device types | — | Below |
| Taiwan | TFDA | Manufacturer | VERDENT LTD. | 2 | 2017–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | VERDENT LTD. | 1 | 2019–2019 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Verdent LTD. | 1 | 2019–2019 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | VERDENT | 1 | 2026–2026 | 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 Verdent Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Verdent | 2016 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Verdent mouth mirrors | 2025 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Verdent dental instruments | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Verdent | 2016 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Verdent Gutta Percha points | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Verdent endodontic instruments | 2025 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Verdent dental scalers | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VERDENT LTD.FDA reg. 3012628066 | LODZ Lodzkie, Poland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052364). 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.