Manufacturer registered with FDA
Adwin Korea Corporation
Gangnam-gu, South Korea. 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
- 44 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Adwin Korea Corporation 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 | Adwin Korea Corporation | 2 device types | — | Below |
| Brazil | ANVISA | Manufacturer | ADWIN KOREA CORPADWIN KOREA CORPORATION | 2 | 2009–2013 | Pure Global AI |
| Israel | AMAR | Manufacturer | Adwin Korea Corporation | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ADWIN KOREA CORP. | 1 | 2010–2010 | 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 Adwin Korea Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Baby Teeth Wipes | 2006 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Finger Teeth Wipes | 2007 |
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 |
|---|---|---|
| ADWIN KOREA CORP.FDA reg. 3004102812 | Gangnam-gu Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9083346). 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.