BioRoot RCS Liquid Refill Kit

GUDID 03760140704516

Mixing Solution single dose container (20x 0.20mL)

SEPTODONT SAS SPECIALITES SEPTODONT

Endodontic filling/sealing material

• Primary Device ID: 03760140704516
• NIH Device Record Key: 30603082-0653-444a-a7b0-2429b0b3bcf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioRoot RCS Liquid Refill Kit
• Version Model Number: 01E0310
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• 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: true
• Device Combination Product: false
• Single Use: true
• 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

Customer Support Contacts

• Phone: 1-303-665-7535
• Email: usregulatoryaffairs@septodont.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760140704516 [Primary]

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: 2019-07-11
• Device Publish Date: 2019-07-03

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