AxioCAL

Basic Information

• Brand Name: AxioCAL
• Primary DI: D161250100
• Version / Model: 25010 Intro Pack
• Company Name: Axiodent Inc.
• Labeler DUNS: 119330625
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-04
• Public Version: 1
• Public Version Date: 2024-10-14
• Public Version Status: New
• Public Device Record Key: 4552549d-2b24-4d11-975d-625a2a7041bf

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: 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
EJK	Liner, Cavity, Calcium Hydroxide	Dental	872.3250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62199	Calcium hydroxide dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. 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	D161250100	HIBCC