Meta P&Bond

GUDID 08806387894100

Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bonding agent is one-step for priming and bonding. It is formulated to adhesively bond to hard surfaces of the oral cavity, namely enamel and dentin, for use with dental cements. It is useful as a primer for use with other methacrylate cements. It is intended to be painted on the interior of a prepared cavity or surface of a tooth to improve retention of a restoration such as a filling or crown. It also is useful as a prime and bonder for porcelain veneer luting, bonding composite to composite, and composite to metal/amalgam. Meta P&Bond is packaged with Microbrush accessories.

Meta Biomed Co., Ltd.

Dentine bonding agent/set

• Primary Device ID: 08806387894100
• NIH Device Record Key: ca5f9487-85ea-40cd-b0a7-90abed813929
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meta P&Bond
• Version Model Number: 9410
• 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	08806387894100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180802

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 3
• Public Version Date: 2020-04-13
• Device Publish Date: 2018-11-19

On-Brand Devices [Meta P&Bond]

• 08806387894100: Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bondin
• 08806387892212: Meta P&Bond is a wet bond adhesive system that is activated by visible light curing. This bondin