Identity
- Trade Name
- SI FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- 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. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. FDA UDI
- Model / Reference
- SHAR3520 FDA UDI
- Description
- 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. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809457208548 FDA UDI
- 510(k) Number
- K223395 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 Conditional 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
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- 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
K223395 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 75ddf1ef-d7a6-4483-b482-4686e0ff9c1e 35 fields · synced Jun 7, 2026