FDA UDI
In Commercial Distribution
🇺🇸 United States
Short Drill Kit
DI: 08806343922298
·
Model: LCB50S
·
Shinhung MST Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Short Drill Kit
- Primary DI
- 08806343922298
- Version / Model
- LCB50S
- Company Name
- Shinhung MST Co., Ltd.
- Labeler DUNS
- 689667152
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-16
- Public Version
- 1
- Public Version Date
- 2025-06-24
- Public Version Status
- New
- Public Device Record Key
- ee64ac8c-7617-4885-bf82-fc68505fa8c3
Device Description
This product is a dental implant drill used to form installation holes according to the type of fixture when performing dental implant fixture surgery. It is used for cortical bone expansion after forming the final drill hole.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45714 | Fixture/appliance dental drill bit, reusable | A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806343922298 | GS1 |
Customer Contacts
- Phone
- +82337301913
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius