Freeprint denture flex pink-transparent 1.000g

GUDID EDET047011

DETAX GmbH

Denture reliner, elastic, long-term

• Primary Device ID: EDET047011
• NIH Device Record Key: 3ed63e15-650d-4346-9023-eeb529ad540a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freeprint denture flex pink-transparent 1.000g
• Version Model Number: 04701
• Company DUNS: 343947949
• Company Name: DETAX GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDET047011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252430

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2025-11-26
• Device Publish Date: 2025-11-18

Devices Manufactured by DETAX GmbH

• EDET047181 - RS VIVO Denture Flex transparent 1000g: 2025-11-28
• EDET047191 - RS VIVO Denture Flex pink transparent 1000g: 2025-11-28
• EDET047201 - RS VIVO Denture Impact pink 1000g: 2025-11-28
• EDET047211 - RS VIVO Denture Impact pink transparent 1000g: 2025-11-28
• EDET047221 - RS VIVO IBT 1000g: 2025-11-28
• EDET047231 - RS VIVO Splint Flex 1000g: 2025-11-28
• EDET047241 - RS VIVO Splint Hard 1000g: 2025-11-28
• EDET047011 - Freeprint denture flex pink-transparent 1.000g: 2025-11-26
• EDET047011 - Freeprint denture flex pink-transparent 1.000g: 2025-11-26