Dual Cure Resin Cement Opaque (Universal Opaque) 8g

GUDID 06972220484417

Rizhao HuGe Biomaterials Company, Ltd.

Dental composite resin

• Primary Device ID: 06972220484417
• NIH Device Record Key: d72c3899-a608-4c65-abf7-0ca89bc28c23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Cure Resin Cement
• Version Model Number: Automix
• Catalog Number: Opaque (Universal Opaque) 8g
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972220484417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201790

FDA Product Code

• EMA: Cement, Dental

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: 2022-01-07
• Device Publish Date: 2021-12-30

On-Brand Devices [Dual Cure Resin Cement]

• 06972220484363: Automix
• 06972220484417: Automix
• 06972220484400: Automix
• 06972220484394: Automix
• 06972220484387: Automix
• 06972220484370: Automix
• 06972220488644: Automix