Duns Number:316699578
Device Description: Easy Glaze is a nanofilled, light-cured coating with natural fluorescence forsealing surfa Easy Glaze is a nanofilled, light-cured coating with natural fluorescence forsealing surfaces.
Catalog Number
1016
Brand Name
Easy Glaze
Version/Model Number
1016
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
K082285
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
4c8e9401-3a5e-4ec8-9737-968dbe13f272
Public Version Date
June 13, 2019
Public Version Number
1
DI Record Publish Date
June 05, 2019
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 |