Signum matrix 66019698

GUDID J014660196980

Signum matrix, OTA, 4 g

Kulzer GmbH

Dental prosthesis veneer resin

• Primary Device ID: J014660196980
• NIH Device Record Key: df6148f4-df69-4e20-9606-5544abdcffa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signum matrix
• Version Model Number: 66019698
• Catalog Number: 66019698
• 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	J014660196980 [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 matrix]

• J014660306700: Signum matrix, MD3, 4 g
• J014660306690: Signum matrix, SD2, 4 g
• J014660197060: Signum matrix, VL4, 4 g
• J014660197050: Signum matrix, VL3, 4 g
• J014660197040: Signum matrix, VL2, 4 g
• J014660197030: Signum matrix, VL1, 4 g
• J014660197020: Signum matrix, OTice, 4 g
• J014660197010: Signum matrix, OTY, 4 g
• J014660197000: Signum matrix, OTG, 4 g
• J014660196990: Signum matrix, OTB, 4 g
• J014660196980: Signum matrix, OTA, 4 g
• J014660196970: Signum matrix, OS4, 4 g
• J014660196960: Signum matrix, OS3, 4 g
• J014660196950: Signum matrix, OS2, 4 g
• J014660196940: Signum matrix, OS1, 4 g
• J014660196930: Signum matrix, SD1, 4 g
• J014660196920: Signum matrix, MD2, 4 g
• J014660196910: Signum matrix, MD1, 4 g
• J014660196800: Signum matrix, OT10, 4 g
• J014660196790: Signum matrix, OT5, 4 g
• J014660196780: Signum matrix, OT2, 4 g
• J014660196770: Signum matrix, OT1, 4 g
• J014660196750: Signum matrix (set)