Sparkle™ EZ Contra Angle
Prophy Angle, Soft Cup, Purple
9manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Crosstex International, United States |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K030603 |
| Record published | 2022-09-29 |
| Record revised | 2023-06-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Pack of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TPAFEZ | 100 | In distribution | |
| TPASEZ | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 366 |
| Young | Young Dental Manufacturing I, LLC | 94 |
| Henry Schein | Henry Schein, Inc. | 84 |
| StarDental Instrument Solutions | Dentalez, Inc. | 63 |
| Maxso | Beyes Dental Canada, Inc. | 42 |
| Nupro® | Dentsply Professional | 35 |
| AllPro | Team Technologies, Inc. | 30 |
| Medidenta | Medidenta | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 23 |
| Maxima | Henry Schein, Inc. | 21 |
| Denticator | Young Dental Manufacturing I, LLC | 19 |
| Henry Schein | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 247. All products under Handpiece, Contra- And Right-Angle Attachment, Dental
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.