Oxford Root FILL System

GUDID E15002

Dual Cure Permanent Root Canal Sealing and Filling Material

First Scientific Dental Materials GmbH

Endodontic filling/sealing material

• Primary Device ID: E15002
• NIH Device Record Key: 08c8183f-f8c6-4ca3-bf37-19b294239e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxford Root FILL System
• Version Model Number: 15-002
• Company DUNS: 341553292
• Company Name: First Scientific Dental Materials GmbH
• Device Count: 2
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de
• Phone: +494121909508
• Email: info@oxford-scientific.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E15002 [Unit of Use]
HIBCC	EFSM150020 [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: 2020-12-02
• Device Publish Date: 2020-11-24

Devices Manufactured by First Scientific Dental Materials GmbH

• EFSM100070 - Oxford SpheriChrome: 2022-03-14 One Material Thousand Shades - Light Cure Restorative Composite
• EFSM100100 - Oxford SpheriBlokk: 2022-03-14 Blocker for Oxford SpheriChrome - Light Cure Restorative Composite
• EFSM12001BLUE0 - Oxford Zircore NANO Blue: 2020-12-02 Premium Dual cure Core Build-up and Post Cementing Composite
• EFSM12005A30 - Oxford Flo CEM A3: 2020-12-02 Dual Cure Flowable Composite Cement
• E12013A2 - Oxford Zircore NANO A2: 2020-12-02 Premium Dual cure Core Build-up and Post Cementing Composite
• E15002 - Oxford Root FILL System: 2020-12-02Dual Cure Permanent Root Canal Sealing and Filling Material
• E15002 - Oxford Root FILL System: 2020-12-02 Dual Cure Permanent Root Canal Sealing and Filling Material
• EFSM210050 - Oxford Universal Bond: 2020-12-02 Universal Adhesive
• EFSM30001A30 - Oxford Temp A3: 2020-12-02 Temporary Crown & Bridge Material 10:1