Identity
- Trade Name
- Luna EUDAMEDSI FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Sterile & non-sterile dental implant system EUDAMED25 Angled Abutment 4.5 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
- SAA4525N20 EUDAMEDFDA UDI
- Description
- 25 Angled Abutment 4.5 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
- 08809457207244 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809457207244 EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 7 Millimeter FDA UDIOuter Diameter — 4.6 Millimeter FDA UDILength — 11.1 Millimeter FDA UDILength — 12.1 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Si by Shinhung MST Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
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.
K160106 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shinhung MST Co., Ltd.
Sources (2)
- FDA UDI 94f40b29-7bc8-44ee-aa10-261e776106fb 37 fields · synced Jul 20, 2026
- EUDAMED 5f28b714-a68c-400f-9aa9-2f60e72925aa 61 fields · synced Jul 20, 2026