bioplast 25 shore 8 x 50ml

GUDID EDET028921

DETAX GmbH

Earmould, custom-made

• Primary Device ID: EDET028921
• NIH Device Record Key: 58b0a386-e963-41c0-b46d-a600c960f4f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioplast 25 shore 8 x 50ml
• Version Model Number: 02892
• Company DUNS: 343947949
• Company Name: DETAX GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	EDET028921 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air-Conduction, Prescription

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: 2024-09-05
• Device Publish Date: 2024-08-28

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• EDET045911 - VITA VIONIC® DENT RESIN A2 1000g: 2025-06-23
• EDET045921 - VITA VIONIC® DENT RESIN A3 1000g: 2025-06-23
• EDET045931 - VITA VIONIC® DENT RESIN B1 1000g: 2025-06-23
• EDET045941 - VITA VIONIC® DENT RESIN B3 1000g: 2025-06-23