Data / Medical devices / South Korea / Dentis Medical Division
Dentis Medical Division: FDA-registered device maker in Dong-gu Daegu, South Korea, 2 510(k) clearances
Dentis Medical Division is registered with the FDA (registration 3033509587) in Dong-gu Daegu, South Korea. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033509587
- Address
- F1, 102, 87, Yuram-ro, Dong-gu Daegu, South Korea, 41059
- Owner or operator
- Dentis Co., Ltd. (10025697)
- Roles
- Manufacturer
- First device listed
- February 19, 2024
- Registered through
- 2026
- Brand names listed
- ChecQ (AC100), Luvis Chair (LC700C), Luvis Chair (LC700C-chair only plus), Luvis Chair (LC700C-chair only)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, With Operative Unit | KLC | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 21, 2025 | K241065 | ChecQ (AC100) | EKX | Substantially Equivalent | Dentis Co., Ltd. | accessdata.fda.gov |
| September 6, 2024 | K233921 | Luvis Chair (LC700C) | KLC | Substantially Equivalent | Dentis Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Dental, Without Operative Unit
- All makers of Chair, Dental, With Operative Unit
- All makers of Unit, Operative Dental
- All makers of Handpiece, Direct Drive, Ac-Powered
Updated March 21, 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.