Data / Medical devices / South Korea / Dentis Medical Division
Dentis Medical Division: FDA-registered device maker in Daegu, South Korea, 2 510(k) clearances
Dentis Medical Division is registered with the FDA (registration 3010373494) in Daegu, South Korea. It lists 10 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
- 3010373494
- Address
- 6 Yuram-ro, Dong-gu, Daegu, South Korea, 41065
- Owner or operator
- Dentis Co., Ltd. (10025697)
- Roles
- Manufacturer
- First device listed
- September 6, 2012
- Registered through
- 2026
- Brand names listed
- ChecQ (AC100), DENOPS, E100 series(E1-M, E1-C, E1-W), L200 Series (Ceiling, Mobile), L2S20-00210 (S200 Chair, S200 Dual Connection), L400 Series (Ceiling, Mobile), LUVIS-C100 Series, LUVIS-C200 Series and more
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 |
| Device, Medical Examination, Ac Powered | KZF | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Surgical | FTD | 2 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Ac-Powered | FQO | 1 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 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 Syringe, Cartridge
- All makers of Device, Medical Examination, Ac Powered
- All makers of Lamp, Surgical
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Chair, Dental, Without Operative Unit
- All makers of Table, Operating-Room, 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.