Duns Number:148312838
Device Description: ALPHA-DENT® Light Cure Bracket Bonding Resin is a Paste-Adhesive system formulated to bond ALPHA-DENT® Light Cure Bracket Bonding Resin is a Paste-Adhesive system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the paste produces an ideal bond and a smooth tacky consistency minimizing bracket floatation. By using the light cure adhesive technology we have eliminated working time contraints. Kit Contains: 1 x 7ml Bracket Bonding Resin
Catalog Number
208.0101.001
Brand Name
ALPHA-DENT® Light Cure Bracket Bonding Resin
Version/Model Number
208.0101.001
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
K935625
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
f4bd85b7-8440-4dfa-9b63-1fc78fadd0e0
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 |