| Primary Device ID | 04560227803397 |
| NIH Device Record Key | ef58d128-bf25-4abf-b14e-f7006e4aff4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iCEM Universal Plus |
| Version Model Number | K223KA |
| Catalog Number | 66101226 |
| Company DUNS | 690922612 |
| Company Name | SUN MEDICAL CO.,LTD. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +1(800)431-1785 |
| customerservice.na@kulzer-dental.com | |
| Phone | +1(800)431-1785 |
| customerservice.na@kulzer-dental.com | |
| Phone | +1(800)431-1785 |
| customerservice.na@kulzer-dental.com |
| Handling Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 33.8 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Keep iCEM Universal Plus Primer away from heat, hot surfaces, sparks, open fl ames, and other ignition sources – no smoking. |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from direct sunlight |
| Handling Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 33.8 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Keep iCEM Universal Plus Primer away from heat, hot surfaces, sparks, open fl ames, and other ignition sources – no smoking. |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from direct sunlight |
| Handling Environment Temperature | Between 1 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 33.8 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Keep iCEM Universal Plus Primer away from heat, hot surfaces, sparks, open fl ames, and other ignition sources – no smoking. |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560227803397 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-17 |
| Device Publish Date | 2026-02-09 |
| 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 |