FDA UDI
In Commercial Distribution
🇺🇸 United States
SIS (Luna)
DI: 08809457208579
·
Model: SHAR3570
·
Shinhung MST Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SIS (Luna)
- Primary DI
- 08809457208579
- Version / Model
- SHAR3570
- Company Name
- Shinhung MST Co., Ltd.
- Labeler DUNS
- 689667152
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-15
- Public Version
- 1
- Public Version Date
- 2023-02-23
- Public Version Status
- New
- Public Device Record Key
- a113c8be-7d74-46d7-8e77-9798fac4183e
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44880 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809457208579 | GS1 |
Customer Contacts
- Phone
- +821099545139
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223395 | 000 |