K-Bond Universal

GUDID 08809262959031

K-Bond Universal 5ml x 1bottle

Spident Co., Ltd.

Dentine bonding agent/set

• Primary Device ID: 08809262959031
• NIH Device Record Key: 928c40f6-957d-4ebf-be1f-1c0774cff824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Bond Universal
• Version Model Number: #370400P01
• Company DUNS: 689370711
• Company Name: Spident 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	08809262959031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241445

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: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [K-Bond Universal]

• 08809262959031: K-Bond Universal 5ml x 1bottle
• 08809262956498: K-Bond Universal mini 2ml x 1bottle