Shinhung MST
Also known as: Shinhung MST Co., Ltd., Shinhung, SHINHUNG
The dental-implant arm of South Korean dental company Shinhung, based in Wonju, maker of the Luna implant system.
Key facts
| Manufacturer | Shinhung MST Co., Ltd.Verified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Headquarters | Wonju, Gangwon-do, South Korea (Munmak-eup)Verified spec[1] |
| Founded | Manufacturer documentation not located(Shinhung is a long-established Korean dental company, but we did not locate a primary statement of the MST implant arm’s founding date.) |
| manufacturingCountry | South KoreaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance7 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K221752 | Stella | Shinhung Mst Co., Ltd. | 2023-06-04 |
| K223395 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | 2023-02-03 |
| K221317 | S-Mono | Shinhung Mst Co., Ltd. | 2023-01-13 |
| K200189 | Luna Dental Implant System- Healing Abutment | Shinhung Mst Co., Ltd. | 2020-02-26 |
| K162867 | MagDen Dental Implant System | Shinhung Mst Co., Ltd. | 2017-07-26 |
| K160106 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2016-08-26 |
| K123155 | LUNA DENTAL IMPLANT SYSTEM | Shinhung Mst Co., Ltd. | 2013-10-31 |
Other2 records
Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3006948193 | — | Shinhung MST Co., Ltd. | — |
| 307 device records | — | Shinhung MST | — |
Clearance records for Shinhung MST were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Shinhung MST.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]FDA 510(k) K223395 — Luna Dental Implant System — U.S. Food & Drug Administration, 2023. Accessed 2026-07-21.
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.