visio.lign color Body A VLCOLBODYA

GUDID EBREVLCOLBODYA9

visio.lign color Body A 2.6 ml

bredent GmbH & Co. KG

Dental prosthesis veneer resin

• Primary Device ID: EBREVLCOLBODYA9
• NIH Device Record Key: 18d92383-dcd9-4754-b23c-95b647284098
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: visio.lign color Body A
• Version Model Number: VLCOLBODYA
• Catalog Number: VLCOLBODYA
• Company DUNS: 341086190
• Company Name: bredent GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBREVLCOLBODYA0 [Primary]
HIBCC	EBREVLCOLBODYA9 [Package]; Contains: EBREVLCOLBODYA0; Package: dummy [1 Units]; Discontinued: 2025-03-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240735

FDA Product Code

• EBD: Coating, filling material, resin

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: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by bredent GmbH & Co. KG

• EBREVLCOLBLACK9 - visio.lign color Black: 2025-03-18 visio.lign color Black 2.6 ml
• EBREVLCOLBLUE9 - visio.lign color Blue: 2025-03-18 visio.lign color Blue 2.6 ml
• EBREVLCOLBODYA9 - visio.lign color Body A: 2025-03-18visio.lign color Body A 2.6 ml
• EBREVLCOLBODYA9 - visio.lign color Body A: 2025-03-18 visio.lign color Body A 2.6 ml
• EBREVLCOLBODYB9 - visio.lign color Body B: 2025-03-18 visio.lign color Body B 2.6 ml
• EBREVLCOLBODYC9 - visio.lign color Body C: 2025-03-18 visio.lign color Body C 2.6 ml
• EBREVLCOLBODYD9 - visio.lign color Body D: 2025-03-18 visio.lign color Body D 2.6 ml
• EBREVLCOLBROWN9 - visio.lign color Brown: 2025-03-18 visio.lign color Brown 2.6 ml
• EBREVLCOLCREME9 - visio.lign color Creme: 2025-03-18 visio.lign color Creme 2.6 ml