AuraLay XF Pit and Fissure Sealant

GUDID D820ALAYXFOW3ML0

Pit and Fissure Sealant, Dental.

DENALI CORPORATION

Dental pit/fissure sealant

• Primary Device ID: D820ALAYXFOW3ML0
• NIH Device Record Key: 4c1d67e9-9489-429b-8222-c00ddbea4e8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuraLay XF Pit and Fissure Sealant
• Version Model Number: 3 mL Opaque White
• 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	D820ALAYXFOW3ML0 [Primary]
HIBCC	D820ALAYXFOW3ML1 [Package]; Package: [2 Units]; In Commercial Distribution
HIBCC	D820ALAYXFOW3ML2 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071158

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

On-Brand Devices [AuraLay XF Pit and Fissure Sealant]

• D820ALAYXFOW3ML0: Pit and Fissure Sealant, Dental.
• D820ALAYXFOW0: Pit and Fissure Sealant, Dental.
• D820ALAYXFNT3ML0: Pit and Fissure Sealant
• D820ALAYXFNT0: Pit and Fissure Sealant, Dental.