Bosworth Sapphire
PEMA Acrylic Impression Material 8 oz Powder Clear
6manufacturers in China registered for this device type
6catalogue numbers in this listing
10510(k) clearances naming this product code
1recall
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 | Harry J. Bosworth Co., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Premarket notification | Exempt |
| Record published | 2016-10-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 32 to 86 °F; Storage environment temperature 0 to 30 °C; Special storage condition: Keep out of direct sunlight; Special storage condition: Keep away from moisture |
| Sizes | Weight 227 g; weight 5 lb; total volume 6 Fluid Ounce; total volume 177 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0921740C | In distribution | |
| 0921744 | Weight 5 lb | In distribution |
| 0921741C | Weight 227 g | In distribution |
| 0921741 | Weight 227 g | In distribution |
| 0921742 | Total Volume 6 Fluid Ounce | In distribution |
| 0921740 | 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 |
|---|---|
| K031439 | 2003-10-02 |
| K994027 | 2000-04-13 |
| K991631 | 1999-07-26 |
| K991489 | 1999-07-15 |
| K991490 | 1999-07-15 |
| K961201 | 1996-05-17 |
| K960063 | 1996-02-14 |
| K940402 | 1994-03-28 |
| K926033 | 1993-05-05 |
| K800548 | 1980-03-18 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-10-13 | Not classified | Other | The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste. | 436 kits | 2006-04-26 |
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.