Manufacturer registered with FDA
Shenzhen Soga Technology Co. Ltd.
Shenzhen, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 56 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Shenzhen Soga Technology 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 | Shenzhen Soga Technology Co. Ltd. | 3 device types | — | Below |
| Peru | DIGEMID | Manufacturer | SHENZHEN SOGA TECHNOLOGY Co., Ltd. | 3 | 2022–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Soga Technology Co Ltd | 1 | 2024–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | SHENZHEN SOGA TECHNOLOGY CO., LTD. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Shenzhen Soga Technology Co., Ltd. | 1 | 2024–2024 | 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 Shenzhen Soga Technology 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 |
|---|---|---|---|---|
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Electric Oral Anesthesia InjectorSmart I,Smart II,Smart III | 2021 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Periodontal Probe SeriesSOGA -T1 | 2021 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AIR-FLY | 2024 |
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 |
|---|---|---|
| SHENZHEN SOGA TECHNOLOGY CO., LTD.FDA reg. 3018318562 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080731). 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.