| Primary Device ID | D8370656050 |
| NIH Device Record Key | b898d0a0-24f4-423c-8622-7865b7012a1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FUSION-Zr - Try-in Paste |
| Version Model Number | Opal White - 1.2ml Syringe |
| Catalog Number | 06-5605 |
| Company DUNS | 067488114 |
| Company Name | Taub Products |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Total Volume | 1.2 Milliliter |
| Total Volume | 1.2 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from heat. Store at room temperature. See SDS. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8370656050 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-05 |
| D8370656050 | FUSION-Zr™ Try-in Paste allows the restoration to be temporarily placed in the patients mouth |
| D8370656000 | FUSION-Zr™ Try-in Paste allows the restoration to be temporarily placed in the patients mouth |