Duns Number:148312838
Device Description: ALPHA-DENT® One Step Bracket Adhesive is a Paste-Primer system formulated to bond to metal ALPHA-DENT® One Step Bracket Adhesive is a Paste-Primer system formulated to bond to metal, ceramic and plastic brackets. The unique filler and primer combination used produces an ideal bond and a smooth tacky viscosity minimizing bracket floatation. Kit Contains: 3.5g Adhesive Syringe
Catalog Number
301.0104.001
Brand Name
ALPHA-DENT® One Step Bracket Adhesive
Version/Model Number
301.0104.001
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
K921044
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
fd9e13e1-19d0-4e57-a588-d9f219a3d346
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 |