Shinhung Luna
Also known as: Luna Dental Implant System, Luna
An internal-hex bone-level implant made by Shinhung MST of South Korea.
Quick facts
| Manufacturer | Shinhung MST Co., Ltd.Verified spec[1] |
|---|---|
| Implant level | Bone-levelVerified spec[2] |
| Material | Grade-4 commercially pure titanium (ASTM F67)Verified spec[1] |
| Surface | Manufacturer documentation not located(The Luna abutment 510(k) we read does not state the fixture surface treatment.) |
| Connection | Internal hexVerified spec[2] |
| Available diameters | Approximately Ø3.7 and Ø4.2–5.7 mmVerified spec[2]Range as recorded in a separate FDA filing that cites the Luna fixture as a reference device. |
| Available lengths | Approximately 8.5–15.0 mmVerified spec[2] |
Overview
Technology
Further detail
| Country | South KoreaVerified spec[1] |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Shinhung Luna. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by Shinhung at brand level and cover its implant range, not Shinhung Luna specifically. We show them here because that is the level at which regulators actually issue them.
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) clearance4 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 |
|---|---|---|---|
| K223395 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | 2023-02-03 |
| K200189 | Luna Dental Implant System- Healing Abutment | Shinhung Mst Co., Ltd. | 2020-02-26 |
| 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 | — |
Clearance records for Shinhung 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.
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]FDA 510(k) K172345 — IU Implant System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.