Duns Number:728534814
Device Description: Light curing, flowable, microhybrid composite. Radiopaque, resin-based dental restorative Light curing, flowable, microhybrid composite. Radiopaque, resin-based dental restorative material for anterior and limited posterior restorations.
Catalog Number
-
Brand Name
BRIGHT LIGHT FLOW
Version/Model Number
A2 Opaque, 2g
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
37ba3559-15ed-4c32-84aa-b691a1592378
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
05206569876048
Quantity per Package
2
Contains DI Package
05206569000726
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |