Fresh adhäsiv D5114

GUDID E239D51141

For the adhesion between impression tray and silicone impression material, high adhesion and still easy cleaning of the tray. 20 ml bottle with brush insert for prefabricated metal or plastic trays. Colour: red.

Dreve Dentamid GmbH

Silicone dental impression material

• Primary Device ID: E239D51141
• NIH Device Record Key: 16ea9dad-4b5c-4bd7-ab22-ac76eb63bb5c
• Commercial Distribution Discontinuation: 2018-07-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fresh adhäsiv
• Version Model Number: 1
• Catalog Number: D5114
• 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 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	E239D51141 [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: 2019-04-09
• Device Publish Date: 2016-10-07

Devices Manufactured by Dreve Dentamid GmbH

• E23912151200501 - FOLIFLEX PRO: 2024-11-08 No.
• E23912151250501 - FOLIFLEX PRO: 2024-11-08 No.
• E23912251200501 - FOLIFLEX PRO: 2024-11-08 No.
• E23912251250501 - FOLIFLEX PRO: 2024-11-08 No.
• E23912401200501 - FOLIFLEX PRO: 2024-11-08 No.
• E23912401250501 - FOLIFLEX PRO: 2024-11-08 No.
• E23920051201001 - FOLIDUR N: 2024-09-19 No.
• E23920051251001 - FOLIDUR N: 2024-09-19 No.