Signum 64714211

GUDID J014647142110

Signum Connector 5mL

Heraeus Kulzer GmbH

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
• 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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• J014660007821 - IOT yellow 96: 2024-09-17 Syringe, Restorative and Impression Material
• J014660009051 - BITE REG INTRAORAL TIP CD 96: 2024-09-17 Syringe, Restorative and Impression Material