Infinix Universal Composite

GUDID 07290017528090

Dental Composite - Translucent

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: 07290017528090
• NIH Device Record Key: 0d144d30-506a-43b4-abb1-429b6c8f245b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinix Universal Composite
• Version Model Number: INF-UC-FP-SD-TR
• Company DUNS: 532282466
• Company Name: NOBIO LTD
• Device Count: 20
• 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	07290017528090 [Unit of Use]
GS1	17290017528097 [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 Universal Composite]

• 07290017528090: Dental Composite - Translucent
• 07290017528083: Dental Composite - B1 shade Single dose
• 07290017528076: Dental Composite - A3 shade Single dose
• 07290017528069: Dental Composite - A2 shade Single dose
• 07290017528052: Dental Composite - A1 shade Single dose
• 17290017528042: Dental Composite - Translucent
• 17290017528035: Dental Composite - B1 shade
• 07290017528021: Dental Composite - A3 shade
• 17290017528011: Dental Composite - A2 shade
• 17290017528004: Dental Composite - A1 shade