Infinix Universal Bond - Bond

GUDID 07290017528304

Universal Bond- Primer 5ml for re-fill kit

NOBIO LTD

Dentine bonding agent/set

• Primary Device ID: 07290017528304
• NIH Device Record Key: f4ddeec2-0d07-49e6-bd19-fa340cee6d25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinix Universal Bond - Bond
• Version Model Number: INF-BOND-PP-MD5ML
• 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: true
• 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	07290017528304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183391

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 2021-03-26
• Device Publish Date: 2021-03-18

Devices Manufactured by NOBIO LTD

• 07290017528298 - Infinix Universal Bond- Bond: 2021-03-26 Universal Bond 2.5ml for starter kit
• 07290017528304 - Infinix Universal Bond - Bond: 2021-03-26Universal Bond- Primer 5ml for re-fill kit
• 07290017528304 - Infinix Universal Bond - Bond: 2021-03-26 Universal Bond- Primer 5ml for re-fill kit
• 17290017528370 - Infinix Universal Bond - Primer: 2021-03-26 Universal Bond- Primer 2.5ml for starter kit
• 07290017528342 - Infinix Universal Bond - Primer: 2021-03-26 Universal Bond- Primer 5ml for re-fill kit
• 17290017528004 - Infinix Universal Composite: 2021-03-23 Dental Composite - A1 shade
• 17290017528011 - Infinix Universal Composite: 2021-03-23 Dental Composite - A2 shade
• 07290017528021 - Infinix Universal Composite: 2021-03-23 Dental Composite - A3 shade
• 17290017528035 - Infinix Universal Composite: 2021-03-23 Dental Composite - B1 shade