AxioGlass

GUDID D161230260

Axiodent Inc.

Dental composite resin kit

• Primary Device ID: D161230260
• NIH Device Record Key: 211baf47-959a-48e0-b0d7-b3a2924dd6ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioGlass
• Version Model Number: 23026 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	D161230260 [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: 2024-11-19
• Device Publish Date: 2024-11-11

On-Brand Devices [AxioGlass]

• D161230300: 23030 1 x 0.5g syringe 3 applicator tips
• D161230280: 23028 4 x 3g syringe 20 applicator tips
• D161230270: 23027 2 x 3g syringe 20 applicator tips
• D161230260: 23026 Intro Pack
• D161230250: 23025 1 x 3g syringe 10 applicator tips
• D161230240: 23024 Trial Pack