Duns Number:036623932
Device Description: Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation Vista’s Chlor-XTRA™ is an enhanced 6% sodium hypochlorite solution designed for irrigation, debridement and cleansing of root canals during and after instrumentation. 3ml pre-filled syringes.
Catalog Number
-
Brand Name
Chlor-XTRA
Version/Model Number
503825
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
KJJ
Product Code Name
Cleanser, Root Canal
Public Device Record Key
49b7c17f-6029-406d-b016-4252798163d4
Public Version Date
December 06, 2021
Public Version Number
3
DI Record Publish Date
August 06, 2018
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 | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |