Accusil Monophase
Accusil Monophase is a dental impression material used to reproduce the structure of a patient’s teeth and gums. The impression supports fabrication of crowns, bridges, occlusal models and…
Accusil Monophase is a dental impression material used to reproduce the structure of a patient’s teeth and gums. The impression supports fabrication of crowns, bridges, occlusal models and dental implant restorations. It is placed in a preformed impression tray for use in the mouth.
The base and catalyst are mixed in equal quantities. The mixture conforms to the teeth and gums while in the tray and sets to retain their shape, creating a reproduction of the dentition and occlusion.
Material
The monophase formulation contains vinyl-terminated polydimethylsiloxanes and fillers with a platinum catalyst and SiH-capped polysiloxane. The impression material has a stated shelf life of three years.
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | Prevest Denpro Limited, India |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Manufacturer |
| 510(k) | K213244 |
| Record published | 2022-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Fast Set 1 x 50ml | In distribution | |
| Regular Set 2 x 50ml | In distribution | |
| Fast Set 1 x 50ml | In distribution | |
| Fast Set 2 x 50ml | In distribution | |
| Regular Set 2 x 50ml | In distribution | |
| Regular Set 1 x 50ml | In distribution | |
| Regular Set 1 x 50ml | In distribution | |
| Fast Set 2 x 50ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213244 | 2022-09-09 |
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.