ARDENT

Basic Information

• Brand Name: ARDENT
• Primary DI: D040600001
• Version / Model: 60000
• Company Name: WHIP-MIX CORPORATION
• Labeler DUNS: 006385173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-05
• Public Version: 1
• Public Version Date: 2025-11-13
• Public Version Status: New
• Public Device Record Key: c52dc860-ce38-41d4-8e65-4f24184d68eb

Device Description

Ardent™ Articulating Paper Premium Thin Blue .0035 Impregnated 140 Strips 88 microns

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFH	Paper, Articulation	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D040600001	HIBCC