iCEM Universal Plus 66101216

GUDID J014661012160

iCEM Universal Plus Mixing Tips

Kulzer GmbH

Dental composite resin

• Primary Device ID: J014661012160
• NIH Device Record Key: b68d702b-a193-49f8-ab78-d41c8937e2cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCEM Universal Plus
• Version Model Number: 66101216
• Catalog Number: 66101216
• 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: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com
• Phone: +1(800)431-1785
• Email: customerservice.na@kulzer-dental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014661012160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K254063

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2026-01-23
• Device Publish Date: 2026-01-15

On-Brand Devices [iCEM Universal Plus]

• J014661012260: iCEM Universal Plus Trial Kit
• J014661012250: iCEM Universal Plus Primer Value Pack
• J014661012240: iCEM Universal Plus Primer
• J014661012230: iCEM Universal Plus Endo Tips
• J014661012220: iCEM Universal Plus Cement Value Pack Transparent
• J014661012210: iCEM Universal Plus Cement Value Pack Opaque
• J014661012200: iCEM Universal Plus Cement Yellow
• J014661012190: iCEM Universal Plus Cement White
• J014661012180: iCEM Universal Plus Cement Translucent
• J014661012170: iCEM Universal Plus Cement Opaque
• J014661012160: iCEM Universal Plus Mixing Tips