C-Root 1

GUDID 06972902581861

Beijing C-Root Dental Medical Devices Co., LTD.

Hygroscopic dental cement

• Primary Device ID: 06972902581861
• NIH Device Record Key: 2adb11b2-1bee-49f8-a188-06b0736f3380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Root
• Version Model Number: 0.5g
• Catalog Number: 1
• Company DUNS: 415018580
• Company Name: Beijing C-Root Dental Medical Devices 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972902581861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212983

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2023-11-21
• Device Publish Date: 2023-11-13

On-Brand Devices [C-Root]

• 16972902583398: 2g
• 16972902583282: 1g
• 06972902583223: 04
• 06972902583216: 06
• 06972902583773: 150325, etc
• 06972902583605: 06-25
• 06972902583568: 04-25
• 06972902583063: C-Root Caulking Putty Paste is specially designed, cellulose-based caulking and block-out materi
• 06972902581861: 0.5g
• 06972902582288: 6g
• 06972902583728: 2g
• 06972902583711: 1g
• 06972902581663: 0.5g