Duns Number:316699578
Device Description: Flowable light-curing base composite.4 mm restorarion base in one simple step.Perfect furf Flowable light-curing base composite.4 mm restorarion base in one simple step.Perfect furface affinity for outstanding adaption.Low shrinkage stress.High radiocapacity (350 %Al).Self-levelling.Can be combined with any methacrylates-based bonding or composite.The non-dripping NDT-syringe or convenient Flow-Caps with bendable metal cannualae ensure a reliable, precisely accurate application.
Catalog Number
1795
Brand Name
x-tra base
Version/Model Number
1795
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
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
4c92d116-f805-4672-9fbc-77d4e0e2f530
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |