Oxford GI Resin PRIME VLC

GUDID EFSM510140

Primer for Resin Modified Glass Ionomer Cement

First Scientific Dental Materials GmbH

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• Primary Device ID: EFSM510140
• NIH Device Record Key: 7c7239a5-4fd5-4ede-ab95-03269ad8d8fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxford GI Resin PRIME VLC
• Version Model Number: 51-014
• Company DUNS: 341553292
• Company Name: First Scientific Dental Materials GmbH
• 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: 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
• 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
• 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	EFSM510140 [Primary]

FDA Product Code

• EMA: Cement, Dental

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

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• 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
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