Promolux High Impact 1020061

GUDID D7091020061

Promolux High Impact Monomer, 500ml

Merz Dental GmbH

Dental appliance fabrication material, resin

• Primary Device ID: D7091020061
• NIH Device Record Key: a39d5dc4-1c02-4410-8c82-306ae1ad2baa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promolux High Impact
• Version Model Number: Promolux High Impact Monomer, 500ml
• Catalog Number: 1020061
• 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
• 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
• Total Volume: 500 Milliliter
• Total Volume: 500 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091020061 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-02-01

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• D7091025121: Promolux High Impact Polymer, L1, 1000g
• D7091025120: Promolux High Impact Polymer, pink, 1000g
• D7091020065: Promolux High Impact Polymer, L1, 100g
• D7091020064: Promolux High Impact Polymer, C34, 100g
• D7091020063: Promolux High Impact Polymer, pink, 100g
• D7091020062: Promolux High Impact Monomer, 100ml
• D7091020061: Promolux High Impact Monomer, 500ml
• D7091020060: Promolux High Impact Monomer, 1000ml