Duns Number:828894373
Device Description: Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.
Catalog Number
GW-SYS-EDTA
Brand Name
Sonendo 17% EDTA
Version/Model Number
FG-008-00001
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
Yes
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
K961089
Product Code
EKL
Product Code Name
Point, Silver, Endodontic
Public Device Record Key
9ee18f4e-4d3e-4359-952f-ab0cef0b6463
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 08, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |