Promolux Polymer Colour CS41 1020016

GUDID D7091020016

Promolux Polymer Colour CS41 1.000g

Merz Dental GmbH

Dental appliance fabrication material, resin

• Primary Device ID: D7091020016
• NIH Device Record Key: 691587a7-1395-4d8d-b8ee-e4587315d4f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promolux Polymer Colour CS41
• Version Model Number: Promolux Polymer Colour CS41 1.000g
• Catalog Number: 1020016
• 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

• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram
• Weight: 1000 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091020016 [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

Devices Manufactured by Merz Dental GmbH

• D7091017910 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA Disc thickness 20mm, diameter 98,5mm, transparent with notch
• D7091019080 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA-Disc, shade clear thickness 16mm, diameter 98,5mm
• D7091019081 - M-PM Disc: 2024-10-21 PMMA-Disc, shade clear thickness 20mm, diameter 98,5mm
• D7091019082 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA-Disc, shade clear thickness 16mm, diameter 100mm
• D7091019083 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA-Disc, shade clear thickness 20mm, diameter 100mm
• D7091019184 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA-Disc, shade clear ZIR thickness 20mm, diameter 95mm
• D7091019205 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA-Disc, shade clear ZIR thickness 25mm, diameter 95mm
• D7091019206 - M-PM Disc: 2024-10-21 M-PM Disc, PMMA-Disc, shade clear ZIR thickness 16mm, diameter 95mm