Duns Number:103056420
Device Description: SST TWIST DRILL, DENTAL, 2.2mm Dia. x 49mm
Catalog Number
-
Brand Name
MicroAire®
Version/Model Number
8051-021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 08, 2022
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTW
Product Code Name
Bit, Drill
Public Device Record Key
2bd017c1-57fe-4694-9d49-040cbeb2ee4e
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
December 30, 2021
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 | 756 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |