Data / Medical devices / South Korea / MegaGen Implant Co., Ltd. (Secheon 2nd factory)
MegaGen Implant Co., Ltd. (Secheon 2nd factory): FDA-registered device maker in Daegu, South Korea, 2 510(k) clearances
MegaGen Implant Co., Ltd. (Secheon 2nd factory) is registered with the FDA (registration 3030089804) in Daegu, South Korea. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 21, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030089804
- Address
- 17-18, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, South Korea, 42921
- Owner or operator
- MEGAGEN IMPLANT CO. LTD (9067358)
- Roles
- Manufacturer
- First device listed
- June 18, 2019
- Registered through
- 2026
- Brand names listed
- 2nd Assi, Dental Light, ML200, N2, N2 (Cart B Type), N2 (Continental Type), N2 (Mount B Type), N2C
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Surgical, Ac-Powered | GBB | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 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, 2024 | K240754 | N2 | EIA | Substantially Equivalent | Megagen Implant Co., Ltd. | accessdata.fda.gov |
| April 5, 2023 | K211556 | N2 | EIA | Substantially Equivalent | Megagen Implant Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Chair, Dental, Without Operative Unit
- All makers of Chair, Surgical, Ac-Powered
- All makers of Light, Operating, Dental
Updated March 21, 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.