Duns Number:320744915
Device Description: Light-curing high-gloss varnish for temporaries. High gloss shine without polishing. Conte Light-curing high-gloss varnish for temporaries. High gloss shine without polishing. Content: 1 bottle @ 5 ml liquid, Accessories
Catalog Number
212075
Brand Name
LuxaGlaze®
Version/Model Number
212075
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
K013179,K013179
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
eff94ae3-7399-4a40-b8f2-1be4daa0ab46
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2120751
Quantity per Package
1
Contains DI Package
EDMG2120750
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 |