dx retainer 5 kg

GUDID EDET047541

DETAX GmbH

Removable dental occlusal splint, custom-made

• Primary Device ID: EDET047541
• NIH Device Record Key: 1a9a5900-66ac-431b-ae2b-aa12d9cfbb88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dx retainer 5 kg
• Version Model Number: 04754
• Company DUNS: 343947949
• Company Name: DETAX GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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	EDET047541 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

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: 2026-03-16
• Device Publish Date: 2026-03-06

Devices Manufactured by DETAX GmbH

• EDET047541 - dx retainer 5 kg: 2026-03-16
• EDET047541 - dx retainer 5 kg: 2026-03-16
• EDET047551 - dx retainer 1000g: 2026-03-16
• EDET030161 - medicalprint shell beige 2.0 1000g: 2026-03-05
• 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
• EDET046351 - VITA VIONIC® BASE RESIN FLEX clear 1000g: 2026-02-12
• EDET047081 - FREEPRINT crown A3,5 1000g: 2026-02-12