Duns Number:081305064
Device Description: POWER DRILL STOP SYSTEM (2mm, 2.5mm, 3.3mm diameter drills and 13 stoppers from 2mm to 14m POWER DRILL STOP SYSTEM (2mm, 2.5mm, 3.3mm diameter drills and 13 stoppers from 2mm to 14mm)
Catalog Number
7812
Brand Name
Power Dental USA
Version/Model Number
7812
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWD
Product Code Name
STARTER, BONE SCREW
Public Device Record Key
8b4a1423-4f23-4d50-ad57-eaf57efa40f5
Public Version Date
May 16, 2022
Public Version Number
4
DI Record Publish Date
June 20, 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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |