Signum 64714211

GUDID J014647142110

Signum Connector 5mL

Heraeus Kulzer GmbH

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: J014647142110
• NIH Device Record Key: d37d0ea8-0cf4-4a00-a42f-0171819d0078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signum
• Version Model Number: 64714211
• Catalog Number: 64714211
• Company DUNS: 315666321
• Company Name: Heraeus 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: false
• 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
• 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	J014647142110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954115

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-18
• Device Publish Date: 2016-09-23

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• J014660390210 - Venus Diamond: 2024-03-14 VENUS DIAMOND PLT REFILL 1x10x0,25G OL
• J014660390220 - Venus Diamond: 2024-03-14 VENUS DIAMOND PLT REFILL 2x10x0,25G OM
• J014660390230 - Venus Diamond: 2024-03-14 VENUS DIAMOND PLT REFILL 2x10x0,25G OD
• J014660982750 - Venus Diamond: 2024-03-14 PROC Venus Diamond Kit 2x20X0.25G PLT
• J014660982760 - Venus Pearl: 2024-03-14 PROC Venus Pearl Kit 2x20X0.2G PLT