Manufacturer registered with FDA
Tianjin Gapadent Co Ltd
TIANJIN, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1021 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name Tianjin Gapadent 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 Gapadent Co Ltd | 3 device types | — | Below |
| Taiwan | TFDA | Manufacturer | TIANJIN GAPADENT CO., LTD | 7 | 2018–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TIANJIN GAPADENT CO LTD | 2 | 2018–2018 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TIANJIN GAPADENT CO., LTD | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | TIANJIN GAPADENT CO., LTD | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | TIANJIN GAPADENT Co LTD.Tianjin Gapadent CO Ltd | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TIANJIN GAPADENT CO. LTD. | 2 | 2018–2018 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | TIANJIN GAPADENT Co., Ltd. | 2 | 2026–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Tianjin Gapadent Co Ltd | 1 | 2021–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | TIANJIN GAPADENT CO., LTD | 1 | 2016–2016 | 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 Gapadent 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 | GAPA | 2004 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | GAPA | 2004 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | GAPA | 2011 |
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 GAPADENT CO., LTD.FDA reg. 3004580125 | TIANJIN, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9063886). 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.