Duns Number:101109114
Device Description: Xtreme K-File 21mm #10 (Package of 6). Endodontic root canal file made from heat treated n Xtreme K-File 21mm #10 (Package of 6). Endodontic root canal file made from heat treated nickel-titanium.
Catalog Number
1K1010
Brand Name
JS Dental Xtreme K-File
Version/Model Number
1K1010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
0b636b2a-8c99-458e-9113-7615aa6c1b26
Public Version Date
December 31, 2020
Public Version Number
2
DI Record Publish Date
November 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-