Infinix Flowable Composite

GUDID 07290017528267

Dental Composite - A1 shade Single dose

NOBIO LTD

Dental composite resin

• Primary Device ID: 07290017528267
• NIH Device Record Key: d48c13b2-0191-47b3-9a83-29a05af8b9af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinix Flowable Composite
• Version Model Number: INF-FL-FP-SD-A1
• Company DUNS: 532282466
• Company Name: NOBIO LTD
• Device Count: 15
• 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
GS1	07290017528267 [Unit of Use]
GS1	17290017528264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201010

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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [Infinix Flowable Composite]

• 07290017528281: Dental Composite - A3 shade Single dose
• 07290017528274: Dental Composite - A2 shade Single dose
• 07290017528267: Dental Composite - A1 shade Single dose
• 17290017528257: Dental Composite - A3 shade Multi dose
• 17290017528240: Dental Composite - A2 shade Multi dose 2g for re-fills kits
• 07290017528205: Dental Composite - A2 shade Multi dose 1g for starter kit
• 17290017528233: Dental Composite - A1 shade