| Primary Device ID | D8375011300 |
| NIH Device Record Key | 1fa5faf9-9f32-42c1-b9a1-5c6651a6a4da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STELLAR iJig |
| Version Model Number | Tooth White Resin - 1 ea 2.5 gm Syr (Bulk) |
| Catalog Number | 50-1130 |
| 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 | 2.9 Gram |
| Weight | 2.9 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 | D8375011300 [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 |