Data / Medical devices / South Korea / Smartooth Co., Ltd.
Smartooth Co., Ltd.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 1 510(k) clearance
Smartooth Co., Ltd. is registered with the FDA (registration 3031568217) in Anyang-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 1, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031568217
- Address
- B-1817B, Anyang IS BIZ Tower Central, 25 Deokcheon-ro 152beon-gil, Manan-gu, Anyang-si Gyeonggi, South Korea, 14084
- Owner or operator
- Smartooth Co., Ltd. (10090784)
- Roles
- Manufacturer
- First device listed
- May 29, 2024
- Registered through
- 2027
- Brand names listed
- SmarTooth
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light-Induced Fluorescence Caries Detector | NBL | 2 | 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 |
|---|---|---|---|---|---|---|
| May 1, 2024 | K231722 | SmarTooth | NBL | Substantially Equivalent | Smartooth Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 1, 2024. 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.