FDA UDI
In Commercial Distribution
🇺🇸 United States
MK Drill Bit
DI: 08800197900167
·
Model: MKDB-DG-08
·
MK Meditech Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MK Drill Bit
- Primary DI
- 08800197900167
- Version / Model
- MKDB-DG-08
- Company Name
- MK Meditech Inc.
- Labeler DUNS
- 695009476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-09
- Public Version
- 1
- Public Version Date
- 2022-06-17
- Public Version Status
- New
- Public Device Record Key
- d70ad0de-0398-44b0-8a76-7fa1f2463668
Device Description
The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is used to mark the ATOZ Mini-Screw placement site or to form a small lead hole to facilitate mini-screw placement by reducing placement resistance. The MK Drill Bit is made of stainless steel (ASTM F899 420B).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43311 | Pin/post dental drill bit | A shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800197900167 | GS1 |