TopCEM Vigor SA Self-Adhesive Resin Cement
TopCEM Vigor SA is a self-adhesive resin cement for fixing indirect dental restorations and posts. It cures through chemical polymerization and can also be activated by light. The base and…
TopCEM Vigor SA is a self-adhesive resin cement for fixing indirect dental restorations and posts. It cures through chemical polymerization and can also be activated by light.
The base and catalyst pastes contain methacrylate resins, MDP and inorganic fillers. A double-barrel syringe dispenses equal volumes of the two pastes, which mix to form the luting cement.
Material and Uses
Fillers make up about 40 percent of the material by volume, and the cement is radiopaque. It is used for ceramic, composite or metal crowns, bridges, inlays, onlays and restorations on implant abutments, as well as fiber posts. Selected short-span bridge applications have additional patient-selection restrictions.
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 | Rizhao Huge Biomaterials Company, Ltd., China |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Manufacturer |
| 510(k) | K252785 |
| Record published | 2026-04-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| / | In distribution | |
| / | In distribution | |
| / | In distribution | |
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| / | In distribution | |
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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 |
|---|---|
| K252785 | 2025-12-12 |
| K241204 | 2024-06-28 |
| K201790 | 2020-09-29 |
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.