Regofix transparent D504877

GUDID E239D5048771

Transparent A-silicone with high final hardness and short setting time for temporary restaurations, bite-registration in difficult cases and x-ray splints. 8 x 50 ml double cartridges

Dreve Dentamid GmbH

Silicone dental impression material

• Primary Device ID: E239D5048771
• NIH Device Record Key: 5f28b466-da12-42de-82e3-3413c0455865
• Commercial Distribution Discontinuation: 2018-05-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Regofix transparent
• Version Model Number: 1
• Catalog Number: D504877
• 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	E239D5048771 [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: 2017-01-24

On-Brand Devices [Regofix transparent]

• E239D5048771: Transparent A-silicone with high final hardness and short setting time for temporary restauratio
• E239D5048761: Transparent A-silicone with high final hardness and short setting time for temporary restauratio