Promolux Polymer CS41 1020015

GUDID D7091020015

Promolux Polymer CS41, 100g

Merz Dental GmbH

Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: D7091020015
• NIH Device Record Key: 8ac8599e-8e4a-41da-9af0-c585b8af27ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promolux Polymer CS41
• Version Model Number: Promolux Polymer CS41, 100g
• Catalog Number: 1020015
• 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: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram
• Weight: 100 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091020015 [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

• D7091019250 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 98,5 mm, thickness 16 mm
• D7091019251 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 98,5 mm, thickness 20 mm
• D7091019252 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 98,5 mm, thickness 25 mm
• D7091019253 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 98,5 mm, thickness 30 mm
• D7091019254 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 95 mm, thickness 16 mm
• D7091019255 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 95 mm, thickness 20 mm
• D7091019256 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 95 mm, thickness 25 mm
• D7091019257 - M-PM Crystal: 2023-04-10 M-PM crystal, diameter 95 mm, thickness 30 mm