Duns Number:067488114
Device Description: Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water soluble formula. Because of its water solubility, and low viscosity, when applied to dental restorations, it acts as a cleansing agent and does not affect bond strengths. This gel is provided in easy to use syringes with flock tips to precisely deliver the gel to the intended areas. External cleaning solution.Go-CHx Gel is recommended for use on dental restorations, prior to insertion. After applying Go-CHx Gel to cleanse the restoration, the surface of the restoration should be rinsed thoroughly with water, and then air dried prior to insertion.
Catalog Number
48-1000
Brand Name
Go-CHx Gel - 0.8% Chlorhexidine
Version/Model Number
Kit - 3 mL Syr - 2 pk
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152322
Product Code
PME
Product Code Name
External Cleaning Solution
Public Device Record Key
90ab2cd3-9657-4c35-bc71-ac036a23d986
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 05, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |