Aura Protective Sealer APS

GUDID D820APS0

Protective Sealer, Dental.

DENALI CORPORATION

Dental pit/fissure sealant Dental pit/fissure sealant

• Primary Device ID: D820APS0
• NIH Device Record Key: d26eabe9-70d9-4927-904d-b699e2e80f45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aura Protective Sealer
• Version Model Number: 1.2 mL Clear
• Catalog Number: APS
• 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

Customer Support Contacts

• Phone: +1-781-826-9190
• Email: denalicorp@denalicorporation.com
• Phone: +1-781-826-9190
• Email: denalicorp@denalicorporation.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D820APS0 [Primary]
HIBCC	D820APS1 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070693

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-05

Devices Manufactured by DENALI CORPORATION

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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.