AxioFlo SE

GUDID D161230190

Axiodent Inc.

Dental composite resin kit

• Primary Device ID: D161230190
• NIH Device Record Key: d5540907-ff25-4047-b278-59b53a1c5cac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioFlo SE
• Version Model Number: 23019 Trial Pack Shades A1 A2 A3 A3.5 B1 or B2
• 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	D161230190 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2024-10-15
• Device Publish Date: 2024-10-07

On-Brand Devices [AxioFlo SE]

• D161230210: 23021 Intro Pack Box Shades A1 A2 A3 A3.5 B1 or B2
• D161230200: 23020 Intro Pack Pouch Shades A1 A2 A3 A3.5 B1 or
• D161230190: 23019 Trial Pack Shades A1 A2 A3 A3.5 B1 or B2