AxioCAL LC

GUDID D161250050

Axiodent Inc.

Calcium hydroxide dental cement

• Primary Device ID: D161250050
• NIH Device Record Key: 8d67fcd8-4deb-4c83-8d89-ae2c29e057dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioCAL LC
• Version Model Number: 25005 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	D161250050 [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 LC]

• D161250170: 25017 Single 0.5g syringe
• D161250060: 25006 Economy Pack
• D161250050: 25005 Intro Pack
• D161250040: 25004 Trial Pack