Manufacturer registered with FDA
Pearl Dent Co Ltd
HOCHIMINH CITY, Vietnam. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 723 registrations outside the US
- Establishments
- 1Vietnam
Registered in 7 markets
Where regulators' registries name Pearl Dent Co 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 | Pearl Dent Co Ltd | 3 device types | — | Below |
| South Korea | MFDS | Manufacturer | PEARL DENT Co. Ltd.,Pearl Dent Co., Ltd. · Pearl Dent Co.,Ltd. · +1 | 8 | 2000–2008 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Pearl Dent Co., Ltd. | 6 | 2026–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Pearl Dent Co Ltd | 3 | 2011–2016 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PEARL DENT CO., LTD | 3 | 2015–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | PEARL DENT CO.,LTD | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | PEARL DENT CO., LTD | 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 Pearl Dent Co 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 NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 2012 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | — | 2002 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | — | 2002 |
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 |
|---|---|---|
| PEARL DENT CO., LTD.FDA reg. 3003637055 | HOCHIMINH CITY Ho Chi Minh, Vietnam | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9049920). 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.