AuraVeneer Cement AVOPW

GUDID D820AVOPW0

Aura Veneer Cement - 1.2 mL Single Syringe Opaque White

DENALI CORPORATION

Dental composite resin

• Primary Device ID: D820AVOPW0
• NIH Device Record Key: 2e3f1772-7d7d-4151-87e7-ac3ff75be78a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuraVeneer Cement
• Version Model Number: 1 Opaque White
• Catalog Number: AVOPW
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D820AVOPW0 [Primary]

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-19

On-Brand Devices [AuraVeneer Cement]

• 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.