iCEM Universal Plus
iCEM Universal Plus Cement Value Pack Translucent
3manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | SUN Medical Co., Ltd., Japan |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K254063 |
| Record published | 2026-02-09 |
| Record revised | 2026-05-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 1 to 25 °C; Handling environment temperature 34 to 77 °F; Special storage condition: Store in a dry place; Special storage condition: Keep iCEM Universal Plus Primer away from heat, hot surfaces, sparks, open fl ames, and other ignition sources → no smok; Special storage condition: Store away from direct sunlight |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| K223KA | In distribution | ||
| K224KA | In distribution | ||
| K226KA | In distribution | ||
| T221KA | In distribution | ||
| T223KA | In distribution | ||
| T224KA | In distribution | ||
| T228KA | 20 | In distribution | |
| K221KA | In distribution | ||
| T225KA | In distribution | ||
| T227KA | 20 | In distribution | |
| T226KA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.