C-Root

GUDID 16972902583398

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

Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement

• Primary Device ID: 16972902583398
• NIH Device Record Key: 0b0a8a28-6a75-4898-9cec-2cad17eaaffb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-Root
• Version Model Number: 2g
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972902583391 [Primary]
GS1	16972902583398 [Package]; Contains: 06972902583391; Package: box [60 Units]; Discontinued: 2022-03-01; Not in Commercial Distribution

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: 2022-03-09
• Device Publish Date: 2022-03-01

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