Qu-resin dentin 54001266

GUDID EBRE540012669

Qu-resin dentin 6 ml Cartridge 1 Piece

bredent GmbH & Co. KG

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: EBRE540012669
• NIH Device Record Key: 8ae27fd0-ebdd-4340-86b7-21e6ec779d50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qu-resin dentin
• Version Model Number: 54001266
• Catalog Number: 54001266
• Company DUNS: 341086190
• Company Name: bredent GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBRE540012660 [Primary]
HIBCC	EBRE540012669 [Package]; Contains: EBRE540012660; Package: dummy [1 Units]; Discontinued: 2023-09-07; Not in Commercial Distribution

FDA Product Code

• EKO: Denture preformed (partially prefabricated denture)

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: 2023-09-15
• Device Publish Date: 2023-09-07

On-Brand Devices [Qu-resin dentin]

• EBRE580012669: Qu-resin dentin 6ml Cartridge 1 Piece
• EBRE540012669: Qu-resin dentin 6 ml Cartridge 1 Piece