U-Cem Premium
Self-Adhesive Universal Resin Cement; Auto-mix 9g(Universal)X2cartridge, mixing tipX10ea, intraoral tipX10ea
3manufacturers in China registered for this device type
20catalogue numbers in this listing
1510(k) clearance
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 | Vericom Co., Ltd., South Korea |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2020-12-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UP109-DU00 | In distribution | |
| UP103-AU0S | In distribution | |
| UP118-DC00 | In distribution | |
| UP109-DC00 | In distribution | |
| UP109-AO01 | In distribution | |
| UP109-AC01 | In distribution | |
| UP109-AU01 | In distribution | |
| UP109-DC01 | In distribution | |
| UP109-AC00 | In distribution | |
| UP118-AC00 | In distribution | |
| UP103-DU0S | In distribution | |
| UP118-DO00 | In distribution | |
| UP109-DO01 | In distribution | |
| UP118-AU00 | In distribution | |
| UP109-DO00 | In distribution | |
| UP118-AO00 | In distribution | |
| UP118-DU00 | In distribution | |
| UP109-AU00 | In distribution | |
| UP109-DU01 | In distribution | |
| UP109-AO00 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193260 | 2020-08-21 |
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.