Riva CEM
Riva Cem is a resin-modified glass-ionomer luting cement for permanent dental cementation. Its radiopaque, fluoride-releasing formulation is supplied as base and catalyst pastes in a…
Riva Cem is a resin-modified glass-ionomer luting cement for permanent dental cementation. Its radiopaque, fluoride-releasing formulation is supplied as base and catalyst pastes in a double-barrel automix syringe.
The universal light-yellow material is delivered in a consistent mixing ratio. Self-curing reactions and light-assisted tack curing support use with different restorative materials.
Listed Item
Riva CEM 1 SYR KT
Restoration Selection
Indications include metal and porcelain-fused-to-metal crowns or bridges, posts and specified orthodontic appliances. High-strength ceramics may be used for crowns, bridges, inlays and onlays; low-strength ceramics are limited to inlays.
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 | SDI Ltd., Australia |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Manufacturer |
| 510(k) | K214118 |
| Record published | 2026-02-16 |
| Record revised | 2026-03-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8800700 | 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 |
|---|---|
| K214118 | 2022-08-30 |
| K073043 | 2007-12-14 |
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.