Duns Number:067488114
Device Description: Glaze Kit contains a translucent acrylic and thinner that gives a gloss coating to provisi Glaze Kit contains a translucent acrylic and thinner that gives a gloss coating to provisional and permanent acrylic, and composite restorations. Glaze is quick setting and cures and bonds to all dental resins, including ethyl and methyl methacrylates, bis-acryl resins, polycarbonates, vinyl methacrylate copolymers, resin crowns and laminates, denture base, acrylic denture teeth and composite resins.
Catalog Number
01-6012
Brand Name
Glaze
Version/Model Number
Kit - 128 oz - Special
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
cced19ec-ae39-4571-b3d3-087539321286
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
September 28, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |