EZ Bond Universal 5.0 (EZB50)

GUDID 08806387860082

EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component.

Meta Biomed Co., Ltd.

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• Primary Device ID: 08806387860082
• NIH Device Record Key: cdaae0f2-b264-4718-9832-bcc043691574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ Bond Universal 5.0 (EZB50)
• Version Model Number: 6008
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., 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: 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	08806387860082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230009

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: 2023-04-20
• Device Publish Date: 2023-04-12

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