Manufacturer registered with FDA
SMENG co.,ltd.
Busan, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1South Korea
Registered in 3 markets
Where regulators' registries name SMENG 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 | SMENG co.,ltd. | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | SM ENG. Co., Ltd.SM ENG CO., LTD. · SM ENG Co., Ltd. · +1 | 5 | 2013–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | SM Eng Co Ltd | 1 | 2018–2018 | 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 SMENG 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 | SM ENG CO.,LTD, | 2014 |
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 |
|---|---|---|
| SMENG CO.,LTD.FDA reg. 3008912461 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044758). 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.