| Primary Device ID | D820AVOW1 |
| NIH Device Record Key | 8eb43d30-99fc-4365-b1b1-f12d1538213a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraVeneer Cement |
| Version Model Number | Off White |
| Catalog Number | AVOW |
| Company DUNS | 191036107 |
| Company Name | DENALI CORPORATION |
| 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 | false |
| 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 | +1-781-826-9190 |
| denalicorp@denalicorporation.com | |
| Phone | +1-781-826-9190 |
| denalicorp@denalicorporation.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D820AVOW [Primary] |
| HIBCC | D820AVOW1 [Package] Contains: D820AVOW Package: [4 Units] In Commercial Distribution |
| EMA | Cement, Dental |
| 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 | 2016-08-04 |
| D820AVOW1 | Cement, Dental. |
| D820AVOPW0 | Aura Veneer Cement - 1.2 mL Single Syringe Opaque White |
| D820AVC0 | Cement, Dental. |
| D820AV3C1OW0 | Cement, Dental. |
| D820AV2C2OW0 | Dental, Cement. |
| D820AV1OW3OPW0 | AuraVeneer Cement. Kit of 4 x 1.2 ml Syringes. Shades: 1 Off White - 3 Opaque White |
| D820AV1C3OW0 | Cement, Dental. |