| Primary Device ID | D820ACEMC0 |
| NIH Device Record Key | b8f6fee9-d3b6-4674-88d7-08b058c03e25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AuraCem DC 90 |
| Version Model Number | Clear |
| Catalog Number | ACEMC |
| 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 | D820ACEMC0 [Primary] |
| 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 |
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| D820ACOREEOW0 - AuraCore Buildup Material | 2018-07-06 Core Buildup Material, Dental. |
| D820ACORENOW0 - AuraCore Buildup Material | 2018-07-06 Core Buildup Material, Dental. |
| D820ALAYNT0 - AuraLay Pit & Fissure Sealant | 2018-07-06 Pit and Fissure Sealant, Dental. |
| D820ALAYNT3ML0 - AuraLay Pit and Fissure Sealant | 2018-07-06 Pit and Fissure Sealant, Dental. |
| D820ALAYOW0 - AuraLay Pit and Fissure Sealant | 2018-07-06 Pit and Fissure Sealant, Dental. |
| D820ALAYOW3ML0 - AuraLay Pit and Fissure Sealant | 2018-07-06 Pit and Fissure Sealant, Dental. |
| D820ALAYXFNT0 - AuraLay XF Pit and Fissure Sealant | 2018-07-06 Pit and Fissure Sealant, Dental. |