Fresh heavy body D90713001

GUDID E239D907130011

Fresh heavy body Mega Pack 380 ml double cartridge incl. 10 tips and 1 bayonet ring.

Dreve Dentamid GmbH

Silicone dental impression material

• Primary Device ID: E239D907130011
• NIH Device Record Key: 2a31df13-422f-4bfd-bea1-8713d6fa9905
• Commercial Distribution Discontinuation: 2019-01-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fresh heavy body
• Version Model Number: 1
• Catalog Number: D90713001
• 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
• 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
• 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	E239D907130011 [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: 2016-10-11

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.