Data / Medical devices / South Korea / Shinhung MST Co., Ltd.
Shinhung MST Co., Ltd.: FDA-registered device maker in Wonju Si Gangwon, South Korea, 7 510(k) clearances
Shinhung MST Co., Ltd. is registered with the FDA (registration 3006948193) in Wonju Si Gangwon, South Korea. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006948193
- Address
- 110-2, Donghwagongdan-Ro Munmak-eup, Wonju Si Gangwon, South Korea, 26365
- Owner or operator
- SHINHUNG MST CO., LTD. (10024874)
- Roles
- Manufacturer
- First device listed
- May 23, 2008
- Registered through
- 2026
- Brand names listed
- AD10, ADH10, ASL, ASS, BAA45, BAT00, BCD14, BCD18 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 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 |
|---|---|---|---|---|---|---|
| June 4, 2023 | K221752 | Stella | DZE | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
| February 3, 2023 | K223395 | Luna Dental Implant System | NHA | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
| January 13, 2023 | K221317 | S-Mono | DZE | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
| February 26, 2020 | K200189 | Luna Dental Implant System- Healing Abutment | NHA | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
| July 26, 2017 | K162867 | MagDen Dental Implant System | DZE | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
| August 26, 2016 | K160106 | LUNA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
| October 31, 2013 | K123155 | LUNA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Shinhung Mst Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Handle, Instrument, Dental
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Attachment, Precision, All
Updated June 4, 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.