Signum cre-active 66020049

GUDID J014660200490

Signum cre-active, white, 3 g

Kulzer GmbH

Dental prosthesis veneer resin

• Primary Device ID: J014660200490
• NIH Device Record Key: ed93dede-1a35-4f50-97c5-1ddaaad2d15e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signum cre-active
• Version Model Number: 66020049
• Catalog Number: 66020049
• Company DUNS: 315666321
• Company Name: Kulzer GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660200490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240660

FDA Product Code

• EBF: Material, tooth shade, 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: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [Signum cre-active]

• J014660334460: Signum cre-active (set)
• J014660200600: Signum cre-active, T2, 3 g
• J014660200590: Signum cre-active, T1, 3 g
• J014660200580: Signum cre-active, black, 3 g
• J014660200570: Signum cre-active, maroon, 3 g
• J014660200540: Signum cre-active, caramel, 3 g
• J014660200530: Signum cre-active, mango, 3 g
• J014660200520: Signum cre-active, corn, 3 g
• J014660200510: Signum cre-active, umbra, 3 g
• J014660200500: Signum cre-active, polar, 3 g
• J014660200490: Signum cre-active, white, 3 g