SIS (Luna)
- Primary DI
- 08809457207558
- Brand
- SIS (Luna)
- Company
- Shinhung MST Co., Ltd.
- Model
- STAR5030H
- Device 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.
- Published
- 2023-02-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NHA | Abutment, Implant, Dental, Endosseous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K223395 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08809457207558 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental implant suprastructure, temporary, preformed, single-use | A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +821099545139 | dlwogml831@shinhung.co.kr |
Regulatory Flags
- DUNS number
- 689667152
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 08806343925541 | evertis | NSSD3508 | 2025-07-28 | |
| 08806343925558 | evertis | NSSD3510 | 2025-07-28 | |
| 08806343925565 | evertis | NSSD3511 | 2025-07-28 | |
| 08806343925572 | evertis | NSSD3513 | 2025-07-28 | |
| 08806343925589 | evertis | NSSD3515 | 2025-07-28 | |
| 08806343925596 | evertis | NSSD4007 | 2025-07-28 | |
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