Duns Number:113170088
Device Description: PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bonding. Phase II®DUAL CURE combines the best of both chemical and light cure polymerization. The chemical cure working time is 4 minutes to allow several brackets to be set and positioned from one mix. An initial set can be immediately achieved by light curing from any angle for 10 seconds. This will prevent the loss of bond strength due to saliva contamination. This unique dual cure process allows complete polymerization under metal brackets where the light does not reach. When an immediate final set is desired, simply light cure a metal or ceramic bracket for 30 seconds. This kit contains paste in 18g jars A & B and 2 X 3cc Sealant Resin and 1 9g etchant. Contains Fluoride
Catalog Number
DCJF
Brand Name
Phase II
Version/Model Number
DCJF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2017
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
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
4dae4b93-acb0-4d4f-a3be-d2bdf94888bd
Public Version Date
November 08, 2018
Public Version Number
5
DI Record Publish Date
August 08, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |