Duns Number:113170088
Device Description: Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visib Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm syringe with 10 tips
Catalog Number
BEGS
Brand Name
Blue Gel Etchant
Version/Model Number
BEGS
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
-
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
c8d3299b-05a4-4ea7-8bf7-bc97dfe0c9ce
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
September 03, 2016
Package DI Number
D798BEGS1
Quantity per Package
5
Contains DI Package
D798BEGS0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |