Identity
- Trade Name
- SI FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- Mount The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function In case of Mount type, it is connected with implant in package and the upper part of the Mount is connected with Mount Driver in implantation. FDA UDI
- Model / Reference
- SMAN01 FDA UDI
- Description
- Mount The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function In case of Mount type, it is connected with implant in package and the upper part of the Mount is connected with Mount Driver in implantation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809458315726 FDA UDI
- 510(k) Number
- K123155 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.6 Millimeter FDA UDILength — 15.2 Millimeter FDA UDI
Category: Dental implant suprastructure kit
Si by Shinhung MST Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123155 also covers:
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
- SI — Shinhung MST Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (1)
- FDA UDI d361374c-ee61-4338-8e4e-f3947b661dca 37 fields · synced Jun 1, 2026