Ceramir® Restore QuikCap
Ceramir Restore QuikCap is a self-curing dental restorative material combining glass-ionomer and calcium-aluminate ceramic cement technologies. It is used for applications including…
Ceramir Restore QuikCap is a self-curing dental restorative material combining glass-ionomer and calcium-aluminate ceramic cement technologies. It is used for applications including non-load-bearing class I and II restorations, cervical restorations, core build-ups, temporary fillings and dentine replacement.
A plastic capsule holds ceramic powder and liquid in separate compartments. Activating the capsule allows them to combine, and a capsule mixer blends the contents. The mixed material is placed into the tooth cavity with the compatible Ceramir Applicator 2.
Finishing
The cement is shaped using conventional filling techniques. After it sets, it can be finished and dry-polished. The material is radiopaque and supplied in the opaque A2 shade.
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 | Doxa Dental AB, Sweden |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| 510(k) | K201937 |
| Record published | 2020-12-31 |
| Record revised | 2023-04-19 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40039 | 5 | In distribution | |
| 40038 | 20 | 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 |
|---|---|
| K201937 | 2020-11-13 |
| K113040 | 2011-12-28 |
| K081405 | 2008-08-21 |
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.