Primary Device ID | D8375011500 |
NIH Device Record Key | ab03c65a-67ec-4fa8-9466-e88a00703bbd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | STELLAR iJig |
Version Model Number | Tooth White Resin - 1ea 5.85 gm Syr (Bulk) |
Catalog Number | 50-1150 |
Company DUNS | 067488114 |
Company Name | Taub Products |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1.201.798.5353 |
customerservice@taubdental.com | |
Phone | +1.201.798.5353 |
customerservice@taubdental.com |
Weight | 5.85 Gram |
Weight | 5.85 Gram |
Special Storage Condition, Specify | Between 0 and 0 *Extremely light sensitive. Keep original cap on syringe directly before and after use. Keep away from heat. Refrigerate. See SDS. |
Special Storage Condition, Specify | Between 0 and 0 *Extremely light sensitive. Keep original cap on syringe directly before and after use. Keep away from heat. Refrigerate. See SDS. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8375011500 [Primary] |
EKO | Denture Preformed (Partially Prefabricated Denture) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-09-06 |
Device Publish Date | 2019-03-19 |
D8375011500 | STELLAR iJig / Tooth White Resin is a dual cure acrylic that light cures in 20 seconds and self |
D8375011400 | STELLAR iJig / Tooth White Resin is a dual cure acrylic that light cures in 20 seconds and self |
D8375011300 | STELLAR iJig / Tooth White Resin is a dual cure acrylic that light cures in 20 seconds and self |