Manufacturer registered with FDA
YMK International
TAIPEI, Taiwan. 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
- 34 registrations outside the US
- Establishments
- 1Taiwan
Registered in 3 markets
Where regulators' registries name YMK International 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 | YMK International | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Y.M.K. International Co., Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | YMK International | 1 | 2006–2006 | 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 YMK International 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 Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Forceps, Dressing | 2011 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Hemostat, Surgical | 2011 |
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 |
|---|---|---|
| Y.M.K. INTERNATIONAL CO., LTD.FDA reg. 8022787 | TAIPEI New Taipei, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8022787). 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.