Manufacturer registered with FDA
Sino-Dentex Co., Ltd.
Changchun, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 12023–2023
- Markets registered in
- 616 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Sino-Dentex 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 | Sino-Dentex Co., Ltd. | 1 clearances | 2023–2023 | Below |
| Serbia | ALIMS | Manufacturer | SINO-DENTEX CO., LTD. | 7 | 2026–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Sino-Dentex Co. Ltd. | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sino-Dentex Co., Ltd. | 2 | 2020–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | Sino-Dentex Co Ltd | 1 | 2021–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | SINO-DENTEX 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 Sino-Dentex 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 |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Apoller | 2021 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | — | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sino-Dentex Co., Ltd. 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: Greenway Yw, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Nov 2018 | K180463 | Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SINO-DENTEX CO.,LTDFDA reg. 3018283083 | Changchun Jilin, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083627). 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.