Infinix Flowable Composite

GUDID 17290017528240

Dental Composite - A2 shade Multi dose 2g for re-fills kits

NOBIO LTD

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 17290017528240
• NIH Device Record Key: 819d2fd0-000a-491e-ac82-bb20898ea384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinix Flowable Composite
• Version Model Number: INF-FL-PP-MD2G-A2
• Company DUNS: 532282466
• Company Name: NOBIO LTD
• 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: false
• 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	07290017528212 [Primary]
GS1	17290017528240 [Package]; Contains: 07290017528212; Package: carton box [1 Units]; In Commercial Distribution

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