Duns Number:078474365
Device Description: EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The s EdgeEndo EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endotontic procedures to remove the smear layer.
Catalog Number
-
Brand Name
EDTA
Version/Model Number
EEEDTA
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
68647e55-5fe3-4058-8783-2060d46b957c
Public Version Date
October 05, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| U | Unclassified | 3 |