Primary Device ID | D820AVC0 |
NIH Device Record Key | 4654fe9a-8c2a-4a0b-9587-9c08bc468ee9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AuraVeneer Cement |
Version Model Number | Clear |
Catalog Number | AVC |
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 | D820AVC0 [Primary] |
HIBCC | D820AVC1 [Package] 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. |