classic futur white 660g

GUDID EDET021361

DETAX GmbH

Earmould impression material

• Primary Device ID: EDET021361
• NIH Device Record Key: 2e0c6d1e-4269-4f55-9fde-004c553d37ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: classic futur white 660g
• Version Model Number: 02136
• 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	EDET021361 [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: 2023-07-11
• Device Publish Date: 2023-07-03

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• EDET045861 - VITA VIONIC® BASE RESIN IMPACT pink-translucent 1000g: 2025-06-23
• EDET045871 - VITA VIONIC® TRY-IN RESIN A2 1000g: 2025-06-23
• EDET045901 - VITA VIONIC® DENT RESIN A1 1000g: 2025-06-23
• 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