Duns Number:716059766
Device Description: The intended purpose of this device is to improve the efficiency and accuracy of root cana The intended purpose of this device is to improve the efficiency and accuracy of root canal treatment on molar teeth.The device can be used for both mesial and distal root canal treatment.
Catalog Number
08064
Brand Name
NA
Version/Model Number
08064
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJB
Product Code Name
Handle, Instrument, Dental
Public Device Record Key
7384e1d3-da6b-48a0-a904-658b029b5073
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 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 | 163 |