SIS (Luna)
Basic Information
- Brand Name
- SIS (Luna)
- Primary DI
- 08809458310042
- Version / Model
- SBA35R50
- Company Name
- Shinhung MST Co., Ltd.
- Labeler DUNS
- 689667152
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-31
- Public Version
- 6
- Public Version Date
- 2020-07-28
- Public Version Status
- Update
- Public Device Record Key
- 1800f712-1e3b-447e-a2d8-f3ee34f10f6a
Device Description
Ball Abutment Ø3.5 RP 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
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 44879 | Dental implant suprastructure, permanent, preformed | A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809458310042 | GS1 | ||||
| Package | 18809458310049 | GS1 | Box | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +82337301900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123155 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 3.2 | Millimeter | |
| Outer Diameter | 3.6 | Millimeter | |
| Length | 14.17 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius