Duns Number:695009476
Device Description: The MK Drill Bit is an instrument that removes bone in combination with a medical handpiec 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).
Catalog Number
-
Brand Name
MK Drill Bit
Version/Model Number
MKDB-DG-08
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QRQ
Product Code Name
Non-Irrigation Endosseous Dental Implant Drill Bits
Public Device Record Key
d70ad0de-0398-44b0-8a76-7fa1f2463668
Public Version Date
June 17, 2022
Public Version Number
1
DI Record Publish Date
June 09, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |