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…
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
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
Record
Regulatory record for Phase II | Listed by | Reliance Orthodontic Products, Inc., United States |
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-08-10 |
| Record revised | 2018-11-08 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature (15-30 ◦ C) Protect from light. |
| Distribution end date | 2017-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.