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Disposable Prophy Angles
9manufacturers in China registered for this device type
366catalogue numbers in this listing
1510(k) clearance
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 | Premium Plus International Limited, Hong Kong |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2020-01-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 20, case of 4 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B-CTS3399-090RB | 500 | In distribution | |
| C3399-60XA | 100 | In distribution | |
| WS3399-60LV | 100 | In distribution | |
| C3399-60GR | 100 | In distribution | |
| C3399-60PK | 100 | In distribution | |
| C3399-60RD | 100 | In distribution | |
| C3399-60X-261TA | 100 | In distribution | |
| B-WTS3399-60PK | 500 | In distribution | |
| W3399-60DB | 100 | In distribution | |
| B-WT3399-60LB | 500 | In distribution | |
| CT3399-60SA | 100 | In distribution | |
| WTS3399-105SP | 100 | In distribution | |
| B-WT3399-105RB | 500 | In distribution | |
| CTS3399-105RL | 100 | In distribution | |
| 3399-090RL | 100 | In distribution | |
| CT3399-105SG | 100 | In distribution | |
| C3399-105SG | 100 | In distribution | |
| B-WT3399-105SG | 500 | In distribution | |
| B-WS3399-090SG | 500 | In distribution | |
| WT3399-105RL | 100 | In distribution | |
| B-3399-090RL | 500 | In distribution | |
| W3399-60LB | 100 | In distribution | |
| B-W3399-60LV | 500 | In distribution | |
| CS3399-60PK | 100 | In distribution | |
| B-CTS3399-60GR | 500 | In distribution | |
| B-WT3399-60LM | 500 | In distribution | |
| 3399-105RL | 100 | In distribution | |
| WTS3399-60YL | 100 | In distribution | |
| WS3399-60GR | 100 | In distribution | |
| WT3399-090RL | 100 | In distribution | |
| C3399-60R-261FA | 100 | In distribution | |
| CT3399-60RA | 100 | In distribution | |
| B-C3399-090RB | 500 | In distribution | |
| CS399-60OR | 100 | In distribution | |
| WTS3399-090SG | 100 | In distribution | |
| B-W3399-090RB | 500 | In distribution | |
| CS3399-105SP | 100 | In distribution | |
| B-C3399-60XA | 500 | In distribution | |
| B-WT3399-60OR | 500 | In distribution | |
| CTS3399-60YL | 100 | In distribution | |
| CS3399-090SP | 100 | In distribution | |
| WT3399-60SA | 100 | In distribution | |
| B-W3399-60YL | 500 | In distribution | |
| B-WTS3399-60SA | 500 | In distribution | |
| W3399-090SG | 100 | In distribution | |
| CTS3399-60LV | 100 | In distribution | |
| B-CS3399-105RL | 500 | In distribution | |
| WTS3399-60LB | 100 | In distribution | |
| B-C3399-60WT | 500 | In distribution | |
| B-CTS3399-60LV | 500 | In distribution | |
| B-WS3399-105SP | 500 | In distribution | |
| WT3399-60DB | 100 | In distribution | |
| CT3399-60YL | 100 | In distribution | |
| B-CT3399-60YL | 500 | In distribution | |
| B-CTS3399-60RD | 500 | In distribution | |
| B-WTS3399-60LV | 500 | In distribution | |
| W3399-105RL | 100 | In distribution | |
| B-WS3399-60PK | 500 | In distribution | |
| B-WT3399-60GR | 500 | In distribution | |
| CS3399-60LB | 100 | In distribution | |
| CS3399-60WT | 100 | In distribution | |
| CTS3399-090RB | 100 | In distribution | |
| B-C3399-105RL | 500 | In distribution | |
| B-CT3399-60LB | 500 | In distribution | |
| W3399-090F | 100 | In distribution | |
| CT3399-60WT | 100 | In distribution | |
| WS3399-60OR | 100 | In distribution | |
| C3399-60S-261F | 100 | In distribution | |
| B-3399-105SG | 500 | In distribution | |
| CTS3399-090RL | 100 | In distribution | |
| B-CTS3399-60LM | 500 | In distribution | |
| B-CS3399-60DB | 500 | In distribution | |
| B-WS3399-090RL | 500 | In distribution | |
| 3399-090SG | 100 | In distribution | |
| C3399-60RA | 100 | In distribution | |
| B-W3399-105SG | 500 | In distribution | |
| B-WTS3399-60RA | 500 | In distribution | |
| W3399-60RD | 100 | In distribution | |
| B-CTS3399-60PK | 500 | In distribution | |
| CT3399-090RL | 100 | In distribution | |
| B-WT3399-60SA | 500 | In distribution | |
| CTS3399-105SG | 100 | In distribution | |
| C3399-60R-269A | 100 | In distribution | |
| B-WTS3399-60YL | 500 | In distribution | |
| WTS3399-090SP | 100 | In distribution | |
| B-WS3399-105RL | 500 | In distribution | |
| WS3399-60LB | 100 | In distribution | |
| B-CS3399-105SP | 500 | In distribution | |
| B-CS3399-090SP | 500 | In distribution | |
| B-CT3399-090SG | 500 | In distribution | |
| C3399-60R-269 | 100 | In distribution | |
| WS3399-60PK | 100 | In distribution | |
| W3399-60RA | 100 | In distribution | |
| W3399-60LM | 100 | In distribution | |
| CT3399-105RL | 100 | In distribution | |
| W3399-60PK | 100 | In distribution | |
| B-CTS3399-60LB | 500 | In distribution | |
| W3399-090RL | 100 | In distribution | |
| CT3399-60PK | 100 | In distribution | |
| WS3399-105RB | 100 | In distribution | |
| B-C3399-105RB | 500 | In distribution | |
| CS3399-105SG | 100 | In distribution | |
| CT3399-090SP | 100 | In distribution | |
| WS3399-105SG | 100 | In distribution | |
| WTS3399-105SG | 100 | In distribution | |
| B-CTS3399-60SA | 500 | In distribution | |
| B-C3399-60SA | 500 | In distribution | |
| CS3399-105RL | 100 | In distribution | |
| W3399-60OR | 100 | In distribution | |
| B-CS3399-60RA | 500 | In distribution | |
| B-W3399-60RA | 500 | In distribution | |
| B-CT3399-60GR | 500 | In distribution | |
| C3399-60LM | 100 | In distribution | |
| B-C3399-60GR | 500 | In distribution | |
| B-CS3399-60LM | 500 | In distribution | |
| B-CTS3399-105RB | 500 | In distribution | |
| C3399-090SP | 100 | In distribution | |
| B-C3399-60LB | 500 | In distribution | |
| B-CS3399-60SA | 500 | In distribution | |
| W3399-090SP | 100 | In distribution | |
| WS3399-090SP | 100 | In distribution | |
| B-WTS3399-105SG | 500 | In distribution | |
| CT3399-105SP | 100 | In distribution | |
| B-CTS3399-105RL | 500 | In distribution | |
| B-C3399-60DB | 500 | In distribution | |
| CS3399-60XA | 100 | In distribution | |
| WTS3399-60GR | 100 | In distribution | |
| B-WT3399-60LV | 500 | In distribution | |
| B-WTS3399-60OR | 500 | In distribution | |
| B-CT3399-60DB | 500 | In distribution | |
| B-CS3399-60LB | 500 | In distribution | |
| C3399-60S-269 | 100 | In distribution | |
| B-CTS3399-105SG | 500 | In distribution | |
| WS3399-60RA | 100 | In distribution | |
| B-C3399-60RA | 500 | In distribution | |
| WT3399-090SG | 100 | In distribution | |
| CT3399-60LV | 100 | In distribution | |
| W3399-60XA | 100 | In distribution | |
| CTS3399-60GR | 100 | In distribution | |
| B-WT3399-090RL | 500 | In distribution | |
| CS3399-60YL | 100 | In distribution | |
| B-C3399-105SP | 500 | In distribution | |
| B-WS3399-60LM | 500 | In distribution | |
| B-WTS3399-090SP | 500 | In distribution | |
| WT3399-60LM | 100 | In distribution | |
| B-WS3399-105SG | 500 | In distribution | |
| B-WT3399-60WT | 500 | In distribution | |
| B-WTS3399-60GR | 500 | In distribution | |
| C3399-60X-269A | 100 | In distribution | |
| B-CTS3399-60YL | 500 | In distribution | |
| B-CS3399-60LV | 500 | In distribution | |
| WS3399-60YL | 100 | In distribution | |
| C3399-090RB | 100 | In distribution | |
| B-WS3399-105RB | 500 | In distribution | |
| CT3399-60LM | 100 | In distribution | |
| B-CT3399-60XA | 500 | In distribution | |
| C3399-60R-261T | 100 | In distribution | |
| W3399-105RB | 100 | In distribution | |
| CTS3399-090SG | 100 | In distribution | |
| B-CS3399-60RD | 500 | In distribution | |
| WS3399-60DB | 100 | In distribution | |
| W3399-105F | 100 | In distribution | |
| B-C3399-090RL | 500 | In distribution | |
| WTS3399-60XA | 100 | In distribution | |
| WS3399-090RB | 100 | In distribution | |
| CS3399-090RL | 100 | In distribution | |
| B-WT3399-60YL | 500 | In distribution | |
| B-W3399-60XA | 500 | In distribution | |
| B-CT3399-105SP | 500 | In distribution | |
| CTS3399-60SA | 100 | In distribution | |
| B-CT3399-60SA | 500 | In distribution | |
| B-W3399-105RB | 500 | In distribution | |
| CTS3399-105RB | 100 | In distribution | |
| WT3399-60LV | 100 | In distribution | |
| B-WT3399-60DB | 500 | In distribution | |
| B-WTS3399-105RB | 500 | In distribution | |
| WS3399-60RD | 100 | In distribution | |
| WTS3399-60LM | 100 | In distribution | |
| CT3399-090SG | 100 | In distribution | |
| B-WTS3399-60DB | 500 | In distribution | |
| B-CTS3399-60RA | 500 | In distribution | |
| B-W3399-60RD | 500 | In distribution | |
| B-CT3399-090RB | 500 | In distribution | |
| B-WS3399-090SP | 500 | In distribution | |
| CTS3399-60XA | 100 | In distribution | |
| WTS3399-60DB | 100 | In distribution | |
| C3399-60R-261F | 100 | In distribution | |
| B-CS399-60OR | 500 | In distribution | |
| C3399-60X-261T | 100 | In distribution | |
| W3399-60WT | 100 | In distribution | |
| B-WS3399-60RA | 500 | In distribution | |
| CTS3399-60LM | 100 | In distribution | |
| CS3399-60RD | 100 | In distribution | |
| B-C399-60OR | 500 | In distribution | |
| C3399-60S-269A | 100 | In distribution | |
| B-CS3399-090RB | 500 | In distribution | |
| CS3399-60LV | 100 | In distribution | |
| B-WS3399-60LV | 500 | In distribution | |
| B-CT3399-60RA | 500 | In distribution | |
| B-C3399-105SG | 500 | In distribution | |
| WS3399-090RL | 100 | In distribution | |
| B-WS3399-60OR | 500 | In distribution | |
| B-WS3399-60SA | 500 | In distribution | |
| B-WS3399-60RD | 500 | In distribution | |
| CTS3399-60RA | 100 | In distribution | |
| WT3399-60GR | 100 | In distribution | |
| B-W3399-60SA | 500 | In distribution | |
| B-CT3399-090SP | 500 | In distribution | |
| B-CS3399-090RL | 500 | In distribution | |
| B-W3399-60DB | 500 | In distribution | |
| B-CS3399-105RB | 500 | In distribution | |
| B-CTS3399-090RL | 500 | In distribution | |
| B-WTS3399-60LB | 500 | In distribution | |
| B-C3399-60RD | 500 | In distribution | |
| CS3399-60SA | 100 | In distribution | |
| CS3399-090SG | 100 | In distribution | |
| WTS3399-105RB | 100 | In distribution | |
| WS3399-105RL | 100 | In distribution | |
| B-WT3399-090SP | 500 | In distribution | |
| B-CT3399-60LV | 500 | In distribution | |
| CT3399-60XA | 100 | In distribution | |
| B-W3399-60OR | 500 | In distribution | |
| B-W3399-090SP | 500 | In distribution | |
| WTS3399-60PK | 100 | In distribution | |
| B-CS3399-60PK | 500 | In distribution | |
| C399-60OR | 100 | In distribution | |
| WTS3399-60LV | 100 | In distribution | |
| C3399-090SG | 100 | In distribution | |
| C3399-60YL | 100 | In distribution | |
| WS3399-090SG | 100 | In distribution | |
| B-W3399-090RL | 500 | In distribution | |
| CTS3399-090SP | 100 | In distribution | |
| WT3399-60YL | 100 | In distribution | |
| B-W3399-60LB | 500 | In distribution | |
| W3399-60SA | 100 | In distribution | |
| B-3399-105RL | 500 | In distribution | |
| B-CS3399-60WT | 500 | In distribution | |
| B-WS3399-60YL | 500 | In distribution | |
| W3399-105SG | 100 | In distribution | |
| B-CTS3399-60OR | 500 | In distribution | |
| B-WS3399-090RB | 500 | In distribution | |
| B-W3399-60GR | 500 | In distribution | |
| CS3399-105RB | 100 | In distribution | |
| C3399-60SA | 100 | In distribution | |
| B-WTS3399-090RL | 500 | In distribution | |
| C3399-60S-261T | 100 | In distribution | |
| WS3399-60XA | 100 | In distribution | |
| B-CT3399-60PK | 500 | In distribution | |
| C3399-105SP | 100 | In distribution | |
| B-WS3399-60DB | 500 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 17 |
Showing 12 of 247. All products under Handpiece, Contra- And Right-Angle Attachment, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100854 | 2010-12-09 |
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.