AxioFlow

GUDID D161230900

Axiodent Inc.

Dental composite resin kit

• Primary Device ID: D161230900
• NIH Device Record Key: 85964c52-c710-4a56-a59e-80e0dfe23895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AxioFlow
• Version Model Number: 23090 Trial Pack Shade OA2
• 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	D161230900 [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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [AxioFlow]

• D161230990: 23099 Trial Pack Shade Opaque
• D161230980: 23098 Trial Pack Shade Incisal
• D161230970: 23097 Trial Pack Shade Bleach
• D161230960: 23096 Trial Pack Shade G4
• D161230950: 23095 Trial Pack Shade G3
• D161230940: 23094 Trial Pack Shade G2
• D161230930: 23093 Trial Pack Shade G1
• D161230920: 23092 Trial Pack Shade OA3.5
• D161230910: 23091 Trial Pack Shade OA3
• D161230900: 23090 Trial Pack Shade OA2
• D161230890: 23089 Trial Pack Shade OA1
• D161230880: 23088 Trial Pack Shade C3
• D161230870: 23087 Trial Pack Shade C2
• D161230860: 23086 Trial Pack Shade C1
• D161230850: 23085 Trial Pack Shade B3
• D161230840: 23084 Trial Pack Shade B2
• D161230830: 23083 Trial Pack Shade B1
• D161230820: 23082 Trial Pack Shade A4
• D161230810: 23081 Trial Pack Shade A3.5
• D161230800: 23080 Trial Pack Shade A3
• D161230790: 23079 Trial Pack Shade A2