Integra Bond

GUDID 00348783000689

INTEGRA BOND ADHESIVE KIT

PREMIER DENTAL PRODUCTS COMPANY

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• Primary Device ID: 00348783000689
• NIH Device Record Key: d5003b1d-c347-4fde-abde-d5182cfbbb2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Bond
• Version Model Number: 3001421
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: true
• 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	00348783000689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933766

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-10-17
• Device Publish Date: 2016-09-21

On-Brand Devices [Integra Bond]

• 00348783000689: INTEGRA BOND ADHESIVE KIT
• 00348783000665: INTEGRA BOND 4ml
• 00348783000658: INTEGRA AUTO CURE ACTIVATOR 7ml
• 00348783000641: INTEGRA BOND 7ml