Data / Medical devices / Taiwan / Enchant Tek Co. Ltd.
Enchant Tek Co. Ltd.: FDA-registered device maker in Dongshan Township, Yilan County Taipei, Taiwan, 3 510(k) clearances
Enchant Tek Co. Ltd. is registered with the FDA (registration 3012329712) in Dongshan Township, Yilan County Taipei, Taiwan. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012329712
- Address
- No. 210 Xiangzhong Rd., Dongshan Township, Yilan County Taipei, Taiwan, 26950
- Owner or operator
- Enchant Tek Co. Ltd. (10051441)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 18, 2016
- Registered through
- 2026
- Brand names listed
- 3M Dental Floss Pick, 3M ESPE Floss and Toss, 3M Fine Slide Flosser, 3M Toothbrush, AllNEB, AllPEP, Allfow, Mouthpiece and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Contract manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2025 | K242354 | AllNEB | CAF | Substantially Equivalent | Enchant Tek Co. , Ltd. | accessdata.fda.gov |
| February 2, 2024 | K233855 | AllPEP | BWF | Substantially Equivalent | Enchant Tek Co. , Ltd. | accessdata.fda.gov |
| December 13, 2004 | K043148 | ALL FLOW PULMONARY FUNCTION FILTER | CAH | Substantially Equivalent | Alliance Tech Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthpiece, Breathing
- All makers of Floss, Dental
- All makers of Tip, Rubber, Oral Hygiene
- All makers of Toothbrush, Manual
- All makers of Spirometer, Therapeutic (Incentive)
- All makers of Nebulizer (Direct Patient Interface)
Updated April 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.