Weropress Polymer pink 1020045

GUDID D7091020045

Weropress Polymer pink, 100g

Merz Dental GmbH

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• Primary Device ID: D7091020045
• NIH Device Record Key: b3ea8edb-7e52-448c-9abf-14edb0292afd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Weropress Polymer pink
• Version Model Number: Weropress Polymer pink, 100g
• Catalog Number: 1020045
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091020045 [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: 2022-08-09
• Device Publish Date: 2022-08-01

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• 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