PRO3DURE THERMEO Powder

GUDID EPRCD1010119

THERMEO Powder

pro3dure medical GmbH

Custom-made mouthguard

• Primary Device ID: EPRCD1010119
• NIH Device Record Key: 99a41c62-d57a-4a93-a238-fd8d195b1c2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO3DURE THERMEO Powder
• Version Model Number: 180 g Powder - clear transparent
• Company DUNS: 312947842
• Company Name: pro3dure medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com
• Phone: +4923749200500
• Email: info@pro3dure.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPRCD1010119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212017

FDA Product Code

• MQC: Mouthguard, 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: 2022-04-21
• Device Publish Date: 2022-04-13

On-Brand Devices [PRO3DURE THERMEO Powder ]

• EPRCD1010121: THERMEO Powder
• EPRCD1010120: THERMEO Powder
• EPRCD1010119: THERMEO Powder