AuraLay XF Pit and Fissure Sealant

Basic Information

• Brand Name: AuraLay XF Pit and Fissure Sealant
• Primary DI: D820ALAYXFNT3ML0
• Version / Model: 3 mL Natural Translucent
• Catalog Number: ALAYXFNT3
• Company Name: DENALI CORPORATION
• Labeler DUNS: 191036107
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-05
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: dbd6f788-71c7-4a72-a9ee-4b6b40b63679

Device Description

Pit and Fissure Sealant

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	872.3765	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D820ALAYXFNT3ML0	HIBCC
Package	D820ALAYXFNT3ML2	HIBCC		4	In Commercial Distribution
Package	D820ALAYXFNT3ML1	HIBCC		2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K071158	000