AxioIRM 15g powder 10ml liquid

Basic Information

• Brand Name: AxioIRM 15g powder 10ml liquid
• Primary DI: D161280140
• Version / Model: 28014
• Company Name: Axiodent Inc.
• Labeler DUNS: 119330625
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-29
• Public Version: 3
• Public Version Date: 2025-08-18
• Public Version Status: Update
• Public Device Record Key: 1db02a39-85e3-44db-ad4a-9db67fd4bf0b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMB	Zinc Oxide Eugenol	Dental	872.3275	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62200	Zinc oxide eugenol dental cement	A non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components (e.g., rosin/colophony). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D161280140	HIBCC