Data / Medical devices / Taiwan / Lena Ko Corporation
Lena Ko Corporation: FDA-registered device maker in Taipei City, Taiwan, 1 510(k) clearance
Lena Ko Corporation is registered with the FDA (registration 3027283275) in Taipei City, Taiwan. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027283275
- Address
- 7F, No. 33, Sec. 1, Zhongxiao W. Rd., Taipei City, Taiwan, 10041
- Owner or operator
- Lena Ko Corporation (10087600)
- Roles
- Exporter to the US
- First device listed
- March 18, 2023
- Registered through
- 2026
- Brand names listed
- CVS ADV ANGL FLSPK - 897706, CVS ADVCD MNT FLSS - 542218, CVS CMFRT FLSPK - 856262, CVS FINE MNT FLSR - 971455, CVS FLNG CRWN RPR 1CT - 695108, CVS FLS THREADER 35CT - 976521, CVS FLSSR FINE - 454381, CVS FLSSR MINT - 454376 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Floss, Dental | JES | 1 | Exporter to the US | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Exporter to the US | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| January 10, 2013 | K123849 | NEW COMFORT-FIT DENTAL GUARD | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Scraper, Tongue
- All makers of Zinc Oxide Eugenol
- All makers of Mouthguard, Over-The-Counter
- All makers of Toothbrush, Manual
- All makers of Floss, Dental
Updated January 10, 2013. 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.