Duns Number:067488114
Device Description: STELLAR iJig / Tooth White Resin is a dual cure acrylic that light cures in 20 seconds and STELLAR iJig / Tooth White Resin is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for All-on-X pick-up and conversions, build up esthetic PMMA Tooth structure, Implant Verification Jigs, Indexes. Create Pickup Impression Copings. Position misaligning implant components during seating. Connect or fix single implant parts for soldering and welding.
Catalog Number
50-1150
Brand Name
STELLAR iJig
Version/Model Number
Tooth White Resin - 1ea 5.85 gm Syr (Bulk)
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
ab03c65a-67ec-4fa8-9466-e88a00703bbd
Public Version Date
September 06, 2019
Public Version Number
2
DI Record Publish Date
March 19, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |