iCEM Universal Plus 66101216

GUDID 04560227803557

iCEM Universal Plus Mixing Tips

SUN MEDICAL CO.,LTD.

Dental composite resin

• Primary Device ID: 04560227803557
• NIH Device Record Key: 87d99c44-b1be-4df8-b724-6fa438c171f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCEM Universal Plus
• Version Model Number: T227KA
• Catalog Number: 66101216
• Company DUNS: 690922612
• Company Name: SUN MEDICAL CO.,LTD.
• Device Count: 20
• DM Exempt: false
• 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: true
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560227803489 [Primary]
GS1	04560227803557 [Unit of Use]

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: 2026-02-17
• Device Publish Date: 2026-02-09

On-Brand Devices [iCEM Universal Plus]

• 04560227803564: iCEM Universal Plus Endo Tips
• 04560227803557: iCEM Universal Plus Mixing Tips
• 04560227803472: iCEM Universal Plus Primer
• 04560227803465: iCEM Universal Plus Cement Opaque
• 04560227803458: iCEM Universal Plus Cement Yellow
• 04560227803441: iCEM Universal Plus Cement White
• 04560227803434: iCEM Universal Plus Cement Translucent
• 04560227803427: iCEM Universal Plus Primer Value Pack
• 04560227803410: iCEM Universal Plus Cement Value Pack Opaque
• 04560227803403: iCEM Universal Plus Cement Value Pack Translucent
• 04560227803397: iCEM Universal Plus Trial Kit