Duns Number:148312838
Device Description: Alpha-Bond® SE is a 7th generation self-etch adhesive formulated to bond to multiple subst Alpha-Bond® SE is a 7th generation self-etch adhesive formulated to bond to multiple substrates for both direct and indirect bonding procedures. It's a universal adhesive that has the bond strength and durability of a total-etch adhesive while eliminating the etching step. Kit Contains: 1 x 5ml Bottle
Catalog Number
211.0401.002
Brand Name
Alpha-Bond® SE
Version/Model Number
211.0401.002
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
K984503
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
b467dae2-070b-4105-842d-cbc93e81aae5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |