Shinhung

Also known as: Luna, Shinhung MST

The implant brand associated with South Korea’s Shinhung, made by Shinhung MST, whose main implant line is Luna.

Key facts

Manufacturer	Shinhung MST Co., Ltd.Verified spec[1]
Country	South KoreaVerified spec[1]
Connection	Internal hex (Luna Dental Implant System)Verified spec[2]
Material	Grade-4 commercially pure titanium fixture (ASTM F67)Verified spec[1]
manufacturingCountry	South KoreaVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Shinhung’s implants are made by its MST subsidiary in Wonju, and the line most likely to appear on a UK patient’s quotation is Luna, a grade-4 titanium fixture with an internal-hex connection. Shinhung is a broad dental supplier — chairs, materials and instruments as well as implants — so the brand name does not by itself identify the implant; Luna is the specific fixture family to look for.

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.
[3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.