StoneBite® Introduction Package
StoneBite is a dental bite-registration material used to record how a patient’s upper and lower teeth meet. It is also indicated for making a key for intraoral registration. The material is…
StoneBite is a dental bite-registration material used to record how a patient’s upper and lower teeth meet. It is also indicated for making a key for intraoral registration. The material is an addition-curing silicone based on vinylpolysiloxane.
A base and catalyst combine to form the medium-body elastomeric material. The two components are dispensed from a double-cartridge system in a one-to-one ratio through a mixing tip, producing the material used for the occlusal record.
Working Characteristics
StoneBite has a working time of 30 seconds and an intraoral setting time of at least 50 seconds. Its final hardness is 48 plus or minus 2 Shore D.
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 | Dreve Dentamid Gmbh, Germany |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K190571 |
| Record published | 2021-10-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 18 to 28 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D504872A | 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 |
|---|---|
| K190571 | 2019-11-07 |
| K171562 | 2018-04-13 |
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.