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. This kit contains 3 X 6g Phase II Pastes A with Fluoride & B in screw syringes, 2 X 3cc Light Bond Sealant Resins and 1x 9g liquid etchant with and mixing accessories. Kit contains fluoride.
Catalog Number
DCSF
Brand Name
Phase II
Version/Model Number
DCSF
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
0a8f2e44-546e-4cd1-b048-ed72a4b4eae5
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
August 10, 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 |