Data / Medical devices / South Korea / Mgnewton Ltd.
Mgnewton Ltd.: FDA-registered device maker in Gyengsan-si Gyeongbuk, South Korea, 2 510(k) clearances
Mgnewton Ltd. is registered with the FDA (registration 3015396763) in Gyengsan-si Gyeongbuk, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015396763
- Address
- 124, Uisong-gil, Amnyang-eup, Gyengsan-si Gyeongbuk, South Korea, 38552
- Owner or operator
- MGNEWTON Ltd. (10060251)
- Roles
- Manufacturer
- First device listed
- December 27, 2022
- Registered through
- 2026
- Brand names listed
- CURA-Temp, ELEC Master, ELEC Master Dual
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | 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 |
|---|---|---|---|---|---|---|
| May 5, 2023 | K202963 | ELEC Master, ELEC Master Dual | EIA | Substantially Equivalent | Mgnewton , Ltd. | accessdata.fda.gov |
| December 21, 2022 | K202965 | CURA-Temp | EBG | Substantially Equivalent | Mgnewton , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 5, 2023. 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.