Signum composite 66020035

GUDID J014660200350

Signum composite enamel, EM, 4 g

Kulzer GmbH

Dental prosthesis veneer resin

• Primary Device ID: J014660200350
• NIH Device Record Key: a746fbe6-4011-414c-93c3-10dcb5293a4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signum composite
• Version Model Number: 66020035
• Catalog Number: 66020035
• 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	J014660200350 [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]

• J014660200360: Signum composite enamel, ED, 4 g
• J014660200350: Signum composite enamel, EM, 4 g
• J014660200340: Signum composite enamel, EL, 4 g
• J014660200300: Signum composite effect, ET5, 4 g
• J014660200290: Signum composite effect, ET4, 4 g
• J014660200280: Signum composite effect, ET2, 4 g
• J014660200270: Signum composite effect, ET1, 4 g
• J014660200260: Signum composite margin, M4, 4 g
• J014660200250: Signum composite margin, M3, 4 g
• J014660200240: Signum composite margin, M2, 4 g
• J014660200230: Signum composite margin, M1, 4 g
• J014660200210: Signum composite dentine, DD4, 4 g
• J014660200200: Signum composite dentine, DD3, 4 g
• J014660200190: Signum composite dentine, DD2, 4 g
• J014660200180: Signum composite dentine, DC4, 4 g
• J014660200170: Signum composite dentine, DC3, 4 g
• J014660200160: Signum composite dentine, DC2, 4 g
• J014660200150: Signum composite dentine, DC1, 4 g
• J014660200140: Signum composite dentine, DB4, 4 g
• J014660200130: Signum composite dentine, DB3, 4 g
• J014660200120: Signum composite dentine, DB2, 4 g
• J014660200110: Signum composite dentine, DB1, 4 g
• J014660200100: Signum composite dentine, DA4, 4 g
• J014660200090: Signum composite dentine, DA3,5, 4 g
• J014660200080: Signum composite dentine, DA3, 4 g
• J014660200070: Signum composite dentine, DA2, 4 g
• J014660200060: Signum composite dentine, DA1, 4 g