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Sign in to claim this brandShinhung MST Co., Ltd.
US
Last updated May 24, 2026
What Shinhung MST Co., Ltd. makes
Shinhung MST Co., Ltd. manufactures dental implant suprastructures, including permanent and temporary preformed designs, as well as kits for dental implant procedures. Their portfolio also includes screw endosteal dental implants in both one-piece and two-piece configurations, reusable dental drill bits, and various surgical procedure kits for dental and maxillofacial applications. These products are designed for single-use and reusable medical settings, depending on the device type.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under U.S. medical device laws, ensuring compliance with applicable standards for dental and surgical instruments. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shinhung MST Co., Ltd. primarily manufacture?
Shinhung MST Co., Ltd. specializes in dental and maxillofacial medical devices. Their portfolio includes dental implant suprastructures (both permanent and temporary preformed types), screw endosteal dental implants (available in one-piece or two-piece designs), reusable dental drill bits, and various surgical procedure kits. These kits are designed for dental and maxillofacial procedures, with some intended for single-use and others for reusable applications.
Where is Shinhung MST Co., Ltd. based, and how does this affect their regulatory compliance?
Shinhung MST Co., Ltd. is based in the United States, which means their devices are subject to U.S. medical device regulations. Since they operate within the U.S., their products must comply with FDA requirements, including classification under FDA’s regulatory framework (Class I or Class II) and registration in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries or databases list Shinhung MST Co., Ltd.’s devices?
Shinhung MST Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Shinhung MST Co., Ltd.’s devices classified under U.S. regulations?
Shinhung MST Co., Ltd.’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history.
What kinds of surgical kits does Shinhung MST Co., Ltd. produce, and how are they categorized?
Shinhung MST Co., Ltd. manufactures both dental implant procedure kits and general/maxillofacial surgical kits. These kits are categorized based on their intended use—some are designed for single-use (non-medicated), while others are reusable. For example, their dental/maxillofacial surgical kits are reusable, whereas general surgical procedure kits may be intended for single-use applications, depending on the specific product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- shinhung.co.kr
- —
- —
- [email protected]
- Phone
- +821099545139
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689667152
Catalogue (1225)
Page 25 of 25| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| S-Guide Kit | GS50 | FDA UDI | Class I | Active |
| Si | STAR4510 | FDA UDI | Class II | Active |
| Si | SIDAR6074H | FDA UDI | Class II | Active |
| Si | SIDAR5076 | FDA UDI | Class II | Active |
| evertis | TTBCW6631C | FDA UDI | Class I | Active |
| Si | SDAR5042 | FDA UDI | Class II | Active |
| St | STW4511SS | FDA UDI | Class II | Active |
| St | STW5007SS | FDA UDI | Class II | Active |
| Si | SDAN5051 | FDA UDI | Class II | Active |
| Si | SSPAR4041 | FDA UDI | Class II | Active |
| Si | SSPBC40B | FDA UDI | Class I | Active |
| Si | SIDAR5044H | FDA UDI | Class II | Active |
| Si | SSPAR4543 | FDA UDI | Class II | Active |
| Si | SBA35N40 | FDA UDI | Class II | Active |
| St | STBCSR41 | FDA UDI | Class I | Active |
| Si | SICAR4030H | FDA UDI | Class II | Active |
| Si | SDAR6074H | FDA UDI | Class II | Active |
| Si | SFTN40HS | FDA UDI | Class I | Active |
| Luna Dental Implant System | K123155 | FDA 510(k) | Class II | Active |
| Luna Dental Implant System | K160106 | FDA 510(k) | Class II | Active |
| MagDen Dental Implant System | K162867 | FDA 510(k) | Class II | Active |
| Stella | K221752 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Luna Dental Implant System- Healing Abutment | K200189 | FDA 510(k) | Class II | Active |
| Luna Dental Implant System | K223395 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| S-Mono | K221317 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shinhung MST Co., Ltd. Wonju Si Gangwon · KR FEI 3006948193