Identity
- Trade Name
- SI FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing Abutment Ø4.0 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. 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 FDA UDI
- Model / Reference
- SHAN4050 FDA UDI
- Description
- Healing Abutment Ø4.0 NP The Luna Dental Implant System is a device of pure titanium(ASTM F67), titanium alloy(ASTM F136) and gold alloy intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It consists of fixture, abutment, mount, mount screw, cover screw. The fixture’s surface is S.L.A(Sand- Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809457208401 FDA UDI
- 510(k) Number
- K123155 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
Yes
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDILength — 10.2 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Si by Shinhung MST Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 d503c800-0b1f-47d1-9cba-269dd79805bd 37 fields · synced May 31, 2026