Duns Number:276075371
Device Description: Endodontic instruments for professionnal use only
Catalog Number
20102001
Brand Name
K FILES
Version/Model Number
n006 L21 ISO M09
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"
-
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
EKS
Product Code Name
File, Pulp Canal, Endodontic
Public Device Record Key
90ad7f6d-ae3c-4bff-828c-7e5e3a102a12
Public Version Date
July 31, 2020
Public Version Number
1
DI Record Publish Date
July 23, 2020
Package DI Number
J015201020012
Quantity per Package
10
Contains DI Package
J015201020011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Grouping box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |