Duns Number:067488114
Device Description: STELLAR Attachment Resin is a Dual Cure quick curing acrylic perfectly developed for dentu STELLAR Attachment Resin is a Dual Cure quick curing acrylic perfectly developed for denture "Locator" attachment pickups. It light cures in 20 seconds and self cures in 4 minutes.
Catalog Number
50-1500
Brand Name
STELLAR Attachment Resin
Version/Model Number
Pink - 5.85 gm Syringe
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
6fb1889e-b460-41cf-a02f-b2714a44e94c
Public Version Date
March 04, 2020
Public Version Number
1
DI Record Publish Date
February 25, 2020
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 |