Manufacturer registered with FDA
Enchant Tek Co. Ltd.
Dongshan Township, Yilan County, Taiwan. 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
- 34 registrations outside the US
- Establishments
- 1Taiwan
Registered in 3 markets
Where regulators' registries name Enchant Tek 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 | Enchant Tek Co. Ltd. | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Enchant Tek Co., Ltd. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Enchant Tek Co., Ltd.Enchant Tek Co.,Ltd | 2 | 2024–2025 | 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 Enchant Tek 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | 3M Toothbrush | 2016 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | 3M Dental Floss Pick3M ESPE Floss and Toss3M Fine Slide Flosser | 2016 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | soft dental picks | 2017 |
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 |
|---|---|---|
| ENCHANT TEK CO. LTD.FDA reg. 3012329712 | Dongshan Township, Yilan County Taipei, Taiwan | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051441). 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.