Manufacturer registered with FDA
HANSUNG Company
Gimpo-si, South Korea. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 55
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1South Korea
Registered in 2 markets
Where regulators' registries name HANSUNG Company 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 | HANSUNG Company | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | HANSUNG 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 HANSUNG Company 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 | A BETTER TOOTHBRUSHADERERROR TOOTHBRUSHARTPEEL ToothbrushBICHAEME ToothbrushBUSINESS ToothbrushCLASSICAL ToothbrushDENTI Q Toothbrushdentium toothbrushDIA Dental Toothbrushevertis regular toothbrush 39 moreevertis slim orthodonticevertis slim toothbrushevertis wide toothbrushFirst Salt After Rain Toothbrush 1.POSH #600 2.POSH #610 3.POSH N411 4.POSH N500 ToothbrushHAIAN TOOTHBRUSHHIPPO Tour ToothbrushIAN Mini ToothbrushIAN OTTO ToothbrushJEWELRY Design ToothbrushMIRACLE ToothbrushPASTEL ToothbrushPlago, PURE DAWOOM, KINGCHI TOOTHBRUSH, MULTICARE TOOTHBRUSH,PREMINT TOOTHBRUSH (Aqua)PREMINT TOOTHBRUSH (Black)PREMINT TOOTHBRUSH (Brown)PREMINT TOOTHBRUSH (Green)PREMINT TOOTHBRUSH (Ivory Blue)PREMINT TOOTHBRUSH (Ivory Silver)PREMINT TOOTHBRUSH (Orange)PREMINT TOOTHBRUSH (Pink)PREMINT TOOTHBRUSH (Red)PREMINT TOOTHBRUSH (Violet)SALTRAIN, Kosette,COZE C600, COZE C610, COZE C611, Cliniel TeecletoothbrushTOOSTY BLACK TOOTH BRUSHTOOSTY GOLDEN DOOKKEOBI TOOTH BRUSHUnanhi toothbrush - MintUnanhi toothbrush - SkyblueUnanhi toothbrush - VioletUnanhi toothbrush - YellowUnanhi toothbrush-PinkWELLNATURE PROCARE TOOTH BRUSHYUHAN evertisYuhan evertis IMPLANT11.YEGRINA S , 12.YEGRINA H Toothbrush13.E & JOY KIDS SLIM, 14.E & JOY KIDS REGULAR Toothbrush15.ICE CREAM HARD, 16.ICE CREAM 1/2, 17.ICE CREAM SOFT Toothbrush18.EO TIP , 19.JEWELRY 20.IMPLANTCARE-A6 Toothbrush5.TWINKLE #600,6.TWINKLE #610, 7.TWINKLE #411 Toothbrush8.EO FIT 1, 9.EO FIT 2, 10.EO FIT 5 Toothbrush | 2014 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss | 2019 |
| Tongue ScraperLCN · Class 1 | — | Maker | CLENIEL - TEECLE (Double-layered Micro-bristle Tooth brush made of PLA)CLINIEL - TUNCLE (Tongue Cleaner Brush made of PLA)Cliniel Tuncle tonguecleanerTongue Scraper | 2019 |
| Battery-Powered Ionic ToothbrushMMD · Class 1 | Toothbrushes | Maker | Ionic Battery Powered | 2019 |
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 |
|---|---|---|
| HANSUNG COMPANYFDA reg. 3011484062 | Gimpo-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048120). 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.