DTK adhesive opak 54001285

GUDID EBRE540012859

DTK adhesive opak assortment in a double mixing cartridge 5 Parts

bredent GmbH & Co. KG

Dental prosthesis priming agent

• Primary Device ID: EBRE540012859
• NIH Device Record Key: 094576d4-64e5-4887-ab24-aa0c32c8b381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTK adhesive opak
• Version Model Number: 54001285
• Catalog Number: 54001285
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBRE540012850 [Primary]
HIBCC	EBRE540012859 [Package]; Contains: EBRE540012850; Package: dummy [1 Units]; Discontinued: 2023-09-05; Not in Commercial Distribution

FDA Product Code

• EGG: ATTACHMENT, PRECISION, ALL

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: 2023-09-13
• Device Publish Date: 2023-09-05

On-Brand Devices [DTK adhesive opak]

• EBRE540012959: DTK adhesive opak refill pack in a double mixing cartridge 1 x 8 g
• EBRE540012859: DTK adhesive opak assortment in a double mixing cartridge 5 Parts