Duns Number:320744915
Device Description: Light-curing single component bonding agent. Quality fillings in no time. Content: 1 Bottl Light-curing single component bonding agent. Quality fillings in no time. Content: 1 Bottle @ 5 ml of Ecosite Bond.
Catalog Number
220758
Brand Name
Ecosite Bond
Version/Model Number
220758
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
d321a6e7-00b4-4ea6-adab-a9976460a13c
Public Version Date
November 15, 2021
Public Version Number
5
DI Record Publish Date
November 01, 2017
Package DI Number
EDMG2207581
Quantity per Package
1
Contains DI Package
EDMG2207580
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |