Promolux Monomer 1020036

GUDID D7091020036

Promolux Monomer 500ml

Merz Dental GmbH

Dental appliance fabrication material, resin

• Primary Device ID: D7091020036
• NIH Device Record Key: 2d12905c-bbe6-48e4-9b2b-c1e21fbdf407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promolux Monomer
• Version Model Number: Promolux Monomer 500ml
• Catalog Number: 1020036
• Company DUNS: 324914910
• Company Name: Merz Dental 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: 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

Customer Support Contacts

• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de

Device Dimensions

• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091020036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130076

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-06-10

On-Brand Devices [Promolux Monomer ]

• D7091025003: Promolux Monomer, 1000ml
• D7091020036: Promolux Monomer 500ml
• D7091020008: Promolux Monomer, 100ml