Duns Number:789664455
Device Description: Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, w Dent Zar’s Z-Bond is a One-Step Light-Cured Self-Etching Dentin/Enamel Bonding Adhesive, which releases fluorides and does not require mixing, because the adhesive combines properties of etching and bonding in a single bottle. The result is fast and saves chair time. Z-Bond markedly reduces sensitivity due to the fact that the adhesive penetrates the smear layer and adheres to the tooth structure without opening tubules. The work effort is significantly reduced and simplified with Z Bond. All adhesive treatment steps are included in one component. Z Bond is a 7th generation of bonding dentin/enamel adhesives. Z Bond is designed to promote adhesion to tooth structure in the following applications:
Catalog Number
0021
Brand Name
Z Bond-Visible Light Cure One-Step Bonding Adhesive
Version/Model Number
0021
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"
Yes
For Single-Use
Yes
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
fb4b6d57-3cd0-4060-8b93-e2d382726dad
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |