AxioSil Monophase

GUDID D161260080

Axiodent Inc.

Composite dental impression material

• Primary Device ID: D161260080
• NIH Device Record Key: 3f9a3083-7fa7-40f9-b49e-96eb44d509e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioSil Monophase
• Version Model Number: 26008 50ml Fast Set
• 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	D161260080 [Primary]

FDA Product Code

• ELW: Material, Impression

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 [AxioSil Monophase]

• D161260090: 26009 2 x 50ml Fast Set
• D161260080: 26008 50ml Fast Set
• D161260070: 26007 2 x 50ml Regular Set
• D161260060: 26006 50ml Regular Set