Duns Number:101147171
Device Description: Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Nickel Titanium
Catalog Number
1625-00
Brand Name
EZ-Fill Xpress
Version/Model Number
1625-00
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
K063856
Product Code
KIF
Product Code Name
RESIN, ROOT CANAL FILLING
Public Device Record Key
bb4f9bcd-af5e-4ba9-b5e3-e44327a47d58
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 01, 2016
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 | 249 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| U | Unclassified | 3 |