| Primary Device ID | D8370620000 |
| NIH Device Record Key | 1bfb8bc7-093e-40ac-a4e3-b575d5e84155 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FUSION Silane |
| Version Model Number | A |
| Catalog Number | 06-2000 |
| 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 | false |
| 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 | 6 Milliliter |
| Total Volume | 6 Milliliter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from open flame. See SDS. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from open flame. See SDS. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8370620000 [Primary] |
| EBO | Denture Repair Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-26 |
| D8370620200 | Mixing bottle for FUSION Silane. A two-part silane system creating a stronger chemical bond to f |
| D8370620110 | A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic |
| D8370620100 | A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic |
| D8370620010 | A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic |
| D8370620000 | A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic |
| D8370610020 | A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic |
| D8370610000 | A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic |