Duns Number:320744915
Device Description: Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1.5 g composite, Accessories. Color: B1
Catalog Number
224005
Brand Name
LuxaFlow® Ultra
Version/Model Number
224005
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
K011211,K011211
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
823cd423-76ef-4a4f-b2db-8d6dfdc154a6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2240051
Quantity per Package
2
Contains DI Package
EDMG2240050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |