Regofix opak D504875

GUDID E239D5048751

Our classical bite registration material, fast, hard and precise. Very good cutting and milling characteristics. 8 x 50 ml double cartridges.

Dreve Dentamid GmbH

Silicone dental impression material

• Primary Device ID: E239D5048751
• NIH Device Record Key: 9df80f56-6678-4b77-b1d7-3c24bb0b708e
• Commercial Distribution Discontinuation: 2018-05-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regofix opak
• Version Model Number: 1
• Catalog Number: D504875
• Company DUNS: 388000846
• Company Name: Dreve Dentamid 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D5048751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053427

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-10

On-Brand Devices [Regofix opak]

• E239D5048751: Our classical bite registration material, fast, hard and precise. Very good cutting and milling
• E239D5048741: Our classical bite registration material, fast, hard and precise. Very good cutting and milling