Duns Number:005473608
Device Description: G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disp G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposable dispensing dish)
Catalog Number
004217
Brand Name
G-aenial™ Bond
Version/Model Number
004217
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
K082768
Product Code
KLE
Product Code Name
AGENT, TOOTH BONDING, RESIN
Public Device Record Key
25591a89-76de-4c37-ac7a-28121d069086
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |