| Primary Device ID | D820ALAYOW0 |
| NIH Device Record Key | b9399c82-5b07-4347-a3cb-df59a2c7901c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraLay Pit and Fissure Sealant |
| Version Model Number | 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 | D820ALAYOW0 [Primary] |
| HIBCC | D820ALAYOW1 [Package] Package: [4 Units] In Commercial Distribution |
| HIBCC | D820ALAYOW2 [Package] Package: [12 Units] In Commercial Distribution |
| HIBCC | D820ALAYOW3 [Package] Package: [20 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 |
| D820ALAYOW3ML0 | Pit and Fissure Sealant, Dental. |
| D820ALAYOW0 | Pit and Fissure Sealant, Dental. |
| D820ALAYNT3ML0 | Pit and Fissure Sealant, Dental. |