Oxford Cal VLC

GUDID EFSM230010

Light Cure Calcium Hydroxide Liner

First Scientific Dental Materials GmbH

Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement

• Primary Device ID: EFSM230010
• NIH Device Record Key: ebc48512-4523-406f-941d-b340b0445c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxford Cal VLC
• Version Model Number: 23-001
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de
• Phone: +4904121909508
• Email: info@oxford-scientific.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E23001 [Unit of Use]
HIBCC	EFSM230010 [Primary]

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

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: 2020-09-14
• Device Publish Date: 2020-09-06

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: 2020-12-02 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