Manufacturer registered with FDA
Tianjin DiaDent Co., Ltd
TIANJIN CITY, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 485 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Tianjin DiaDent 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 | Tianjin DiaDent Co., Ltd | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | TIANJIN DIADENT CO., LTD. | 65 | 2003–2015 | Pure Global AI |
| South Korea | MFDS | Manufacturer | TIANJIN DIADENT CO.,LTDTIANJIN DIADENT CO., LTD · Tianjin DiaDent Co., Ltd. · +2 | 18 | 1998–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TIANJIN DIADENT CO., LTD | 2 | 2011–2012 | 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 Tianjin DiaDent 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 |
|---|---|---|---|---|
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | GUTTA PERCHA POINTS | 2003 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | STERLI PAPER POINTS | 2003 |
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 |
|---|---|---|
| TIANJIN DIADENT CO., LTD.FDA reg. 3004133229 | TIANJIN CITY, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9058105). 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.