Signum composite flow 66049056

GUDID J014660490560

Signum composite flow dentine, DC2, 4g

Kulzer GmbH

Dental prosthesis veneer resin

• Primary Device ID: J014660490560
• NIH Device Record Key: 5206169d-0a2c-4810-8538-62cd32bd5b5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signum composite flow
• Version Model Number: 66049056
• Catalog Number: 66049056
• 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	J014660490560 [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 composite flow]

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• J014660503460: Signum composite flow cervical, CV1, 4g
• J014660490610: Signum composite flow dentine, DD4, 4g
• J014660490600: Signum composite flow dentine, DD3, 4g
• J014660490590: Signum composite flow dentine, DD2, 4g
• J014660490580: Signum composite flow dentine, DC4, 4g
• J014660490570: Signum composite flow dentine, DC3, 4g
• J014660490560: Signum composite flow dentine, DC2, 4g
• J014660490550: Signum composite flow dentine, DC1, 4g
• J014660490540: Signum composite flow dentine, DB4, 4g
• J014660490530: Signum composite flow dentine, DB3, 4g
• J014660490520: Signum composite flow dentine, DB2, 4g
• J014660490510: Signum composite flow dentine, DB1, 4g
• J014660489450: Signum composite flow dentine, DA4, 4g
• J014660489440: Signum composite flow dentine, DA3,5, 4g
• J014660489430: Signum composite flow dentine, DA3, 4g
• J014660489420: Signum composite flow dentine, DA2, 4g
• J014660489410: Signum composite flow dentine, DA1, 4g