AuraOpaquer AOW

GUDID D820AOW1

Opaquer, Dental.

DENALI CORPORATION

Dental composite resin

• Primary Device ID: D820AOW1
• NIH Device Record Key: 36d53b36-b4f0-44da-98a1-9b73996307dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuraOpaquer
• Version Model Number: 1.2 mL White
• Catalog Number: AOW
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D820AOW0 [Primary]
HIBCC	D820AOW1 [Package]; Contains: D820AOW0; Package: [2 Units]; In Commercial Distribution

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: 2016-08-05

On-Brand Devices [AuraOpaquer]

• D820AOW1: Opaquer, Dental.
• D820AOP0: Opaquer, Dental.