Duns Number:148312838
Device Description: ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials t ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal viscosity allows the material to penetrate into microtubules to enhance mechanical adhesion. Kit Contains: 3ml Base Adhesive, 3ml Catalyst Adhesive, 2 x 4g Etch Gel Syringes, Mixing Pad
Catalog Number
200.0001.001
Brand Name
ALPHA-DENT® Self Cure Bonding Adhesive
Version/Model Number
200.0001.001
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
e9348d49-fc9e-42fa-99fd-3b9776d42fe0
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 |