Duns Number:067488114
Device Description: STELLAR Glaze LC Liquid is a light cure PMMA clear glaze for sealing and creating a luster STELLAR Glaze LC Liquid is a light cure PMMA clear glaze for sealing and creating a luster on acrylic and composite prosthesis and resin teeth. Using blue wavelength LED, full curing takes place in 30 seconds. It is specially formulated to chemically cure without bonding agent to 3D printed and milled try-ins, immediate load full arch temps, long term full arch temps. Applying STELLAR Glaze LC Liquid after pick up and conversion for all chairside conversion arches, it flows into and seals any microgaps. Seals porous PMMA and other resins and increases long term integrity and durability of the prosthesis. STELLAR GLAZE LC Liquid works over STELLAR DC Acrylic and other Pickup resins and is the recommended glaze for Larry’s Magical Denture Elixirs.
Catalog Number
50-3000
Brand Name
STELLAR GLAZE
Version/Model Number
LC LIQUID - 10 ML BTL
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
EKO
Product Code Name
Denture Preformed (Partially Prefabricated Denture)
Public Device Record Key
284e7dd8-0318-44df-8a2b-fd562a1fbb0a
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
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 |