Duns Number:042763706
Device Description: 5.4HD FLAT BTM FIN DRILL CA 31TL 11.5CL II TI NITRIDE RED MARKINGS: 8,10,11.5
Catalog Number
04959201
Brand Name
ACE
Version/Model Number
04959201
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"
-
For Single-Use
-
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
DZA
Product Code Name
DRILL, DENTAL, INTRAORAL
Public Device Record Key
2d69cbb1-0f1e-4f7a-8f6e-2c240908ca86
Public Version Date
October 18, 2019
Public Version Number
1
DI Record Publish Date
October 10, 2019
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 | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |