Light Cure Dental Adhesive 5ml

GUDID 06972220484301

Rizhao HuGe Biomaterials Company, Ltd.

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: 06972220484301
• NIH Device Record Key: bc374b24-b8e3-4d10-a875-ec62228c5d43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Cure Dental Adhesive
• Version Model Number: /
• Catalog Number: 5ml
• Company DUNS: 544452689
• Company Name: Rizhao HuGe Biomaterials Company, 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: 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	06972220484301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201787

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: 2021-12-23
• Device Publish Date: 2021-12-15

Devices Manufactured by Rizhao HuGe Biomaterials Company, Ltd.

• 06972220488644 - Dual Cure Resin Cement: 2023-11-10
• 06972220489009 - TrusFIL-Flow Flowable Composite Restorative: 2023-11-10
• 06972220489030 - TrusFIL-Flow Flowable Composite Restorative: 2023-11-10
• 06972220489085 - TrusFIL Universal Composite Restorative: 2023-11-10
• 06972220489139 - TrusFIL Universal Composite Restorative: 2023-11-10
• 06972220484370 - Dual Cure Resin Cement: 2022-01-07
• 06972220484387 - Dual Cure Resin Cement: 2022-01-07
• 06972220484394 - Dual Cure Resin Cement: 2022-01-07