Duns Number:804495695
Device Description: Aqua Bond Compostie is a light cure, hydrophilic bracket adhesive, which can be applied to Aqua Bond Compostie is a light cure, hydrophilic bracket adhesive, which can be applied to a dry or slightly contaminated surface. The smooth cohesive past viscosity allows for easy application to any style bracket base, insuring maximum mechanical retention.
Catalog Number
CLABC
Brand Name
Aqua Bond Composite
Version/Model Number
CLABC
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
K895522
Product Code
DYH
Product Code Name
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
Public Device Record Key
7a07928f-0510-46f4-b67d-4c90ca0847c4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 22, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |