VITA VIONIC® BASE RESIN FLEX pink transparent 1000g

GUDID EDET046341

DETAX GmbH

Denture reliner, elastic, long-term

• Primary Device ID: EDET046341
• NIH Device Record Key: c46e2cd8-902b-4289-bcef-3696b76991e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITA VIONIC® BASE RESIN FLEX pink transparent 1000g
• Version Model Number: 04634
• 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	EDET046341 [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: 2026-02-12
• Device Publish Date: 2026-02-04

Devices Manufactured by DETAX GmbH

• EDET045881 - VITA VIONIC® DENT RESIN A3,5 500 g: 2026-02-12
• EDET045891 - VITA VIONIC® DENT RESIN A3,5 1000 g: 2026-02-12
• EDET046341 - VITA VIONIC® BASE RESIN FLEX pink transparent 1000g: 2026-02-12
• EDET046341 - VITA VIONIC® BASE RESIN FLEX pink transparent 1000g: 2026-02-12
• EDET046351 - VITA VIONIC® BASE RESIN FLEX clear 1000g: 2026-02-12
• EDET047081 - FREEPRINT crown A3,5 1000g: 2026-02-12
• EDET047091 - FREEPRINT crown A3,5 500g: 2026-02-12
• EDET045581 - medicalprint nobreak blue-transparent 1000g: 2025-12-30
• EDET045631 - medicalprint nobreak dark grey1000g: 2025-12-30