| Primary Device ID | D820ALAYXFOW3ML0 |
| NIH Device Record Key | 4c1d67e9-9489-429b-8222-c00ddbea4e8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraLay XF Pit and Fissure Sealant |
| Version Model Number | 3 mL Opaque White |
| 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 | D820ALAYXFOW3ML0 [Primary] |
| HIBCC | D820ALAYXFOW3ML1 [Package] Package: [2 Units] In Commercial Distribution |
| HIBCC | D820ALAYXFOW3ML2 [Package] Package: [4 Units] In Commercial Distribution |
| EBC | Sealant, Pit And Fissure, And Conditioner |
| 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 | 2016-08-05 |
| D820ALAYXFOW3ML0 | Pit and Fissure Sealant, Dental. |
| D820ALAYXFOW0 | Pit and Fissure Sealant, Dental. |
| D820ALAYXFNT3ML0 | Pit and Fissure Sealant |
| D820ALAYXFNT0 | Pit and Fissure Sealant, Dental. |