Signum metal bond 66033916

GUDID J014660339160

Signum metal bond II, 4 ml

Kulzer GmbH

Dental prosthesis veneer resin

• Primary Device ID: J014660339160
• NIH Device Record Key: 812b1894-7839-4031-bcbb-6ff7f3817381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signum metal bond
• Version Model Number: 66033916
• Catalog Number: 66033916
• 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	J014660339160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240660

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: 2024-11-29
• Device Publish Date: 2024-11-21

On-Brand Devices [Signum metal bond]

• J014660339160: Signum metal bond II, 4 ml
• J014660339150: Signum metal bond I, 4 ml
• J014660339130: Signum metal bond (set)