AxioCAL

GUDID D161250100

Axiodent Inc.

Calcium hydroxide dental cement

• Primary Device ID: D161250100
• NIH Device Record Key: 4552549d-2b24-4d11-975d-625a2a7041bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioCAL
• Version Model Number: 25010 Intro Pack
• Company DUNS: 119330625
• Company Name: Axiodent Inc.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D161250100 [Primary]

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [AxioCAL ]

• D161250110: 25011 Economy Pack
• D161250100: 25010 Intro Pack
• D161250090: 25009 Regular Pack
• D161250080: 25008 Trial Pack