Dual Cure Resin Cement White (White Opaque) 8g

GUDID 06972220484400

Rizhao HuGe Biomaterials Company, Ltd.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 06972220484400
• NIH Device Record Key: 8e7e5e0f-ee18-48f5-a2c9-79e01481cef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Cure Resin Cement
• Version Model Number: Automix
• Catalog Number: White (White 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	06972220484400 [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