Premium Plus
Prophy Cups
49manufacturers in China registered for this device type
115catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (12), Guangdong (12), Anhui (7). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Jung Chen Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
Showing 12 of 49. All 49 manufacturers in China registered for Cup, Prophylaxis
Record
| Listed by | Premium Plus International Limited, Hong Kong |
|---|---|
| FDA product code | EHK |
| Device type | Cup, Prophylaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6290 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| 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 10, box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| T220XA | 100 | In distribution | |
| M222XA | 100 | In distribution | |
| 220-YL | 100 | In distribution | |
| M222LB | 100 | In distribution | |
| 221-LV | 100 | In distribution | |
| T-P222GR | 100 | In distribution | |
| P222SA | 100 | In distribution | |
| T220SA | 100 | In distribution | |
| T-P222SA | 100 | In distribution | |
| 221-DB | 100 | In distribution | |
| T220RD | 100 | In distribution | |
| T220WT | 100 | In distribution | |
| T-P222RD | 100 | In distribution | |
| T-M222RA | 100 | In distribution | |
| T221SA | 100 | In distribution | |
| 220-RD | 100 | In distribution | |
| S221DB | 100 | In distribution | |
| M222RD | 100 | In distribution | |
| P222LV | 100 | In distribution | |
| P222WT | 100 | In distribution | |
| T220LB | 100 | In distribution | |
| S221XA | 100 | In distribution | |
| P222LM | 100 | In distribution | |
| M222DB | 100 | In distribution | |
| T220PK | 100 | In distribution | |
| 221-PK | 100 | In distribution | |
| T220OR | 100 | In distribution | |
| M222LM | 100 | In distribution | |
| 221-YL | 100 | In distribution | |
| T221LB | 100 | In distribution | |
| T-M222XA | 100 | In distribution | |
| P222RA | 100 | In distribution | |
| T221RD | 100 | In distribution | |
| T221LM | 100 | In distribution | |
| T-M222LV | 100 | In distribution | |
| T221YL | 100 | In distribution | |
| T-M222OR | 100 | In distribution | |
| T-M222RD | 100 | In distribution | |
| 220-WT | 100 | In distribution | |
| 221-OR | 100 | In distribution | |
| T221LV | 100 | In distribution | |
| M222WT | 100 | In distribution | |
| S221GR | 100 | In distribution | |
| M222PK | 100 | In distribution | |
| S221SA | 100 | In distribution | |
| T221RA | 100 | In distribution | |
| T-P222WT | 100 | In distribution | |
| 221-LB | 100 | In distribution | |
| 221-SA | 100 | In distribution | |
| S221LV | 100 | In distribution | |
| 220-LV | 100 | In distribution | |
| T-M222LB | 100 | In distribution | |
| 220-PK | 100 | In distribution | |
| P222OR | 100 | In distribution | |
| M222LV | 100 | In distribution | |
| P222YL | 100 | In distribution | |
| T-P222OR | 100 | In distribution | |
| P222LB | 100 | In distribution | |
| T-P222LB | 100 | In distribution | |
| T220LV | 100 | In distribution | |
| T221DB | 100 | In distribution | |
| 221-XA | 100 | In distribution | |
| 221-LM | 100 | In distribution | |
| T220RA | 100 | In distribution | |
| T-P222LV | 100 | In distribution | |
| 221-RA | 100 | In distribution | |
| 221-WT | 100 | In distribution | |
| T-P222RA | 100 | In distribution | |
| T220DB | 100 | In distribution | |
| P222XA | 100 | In distribution | |
| P222GR | 100 | In distribution | |
| S221LM | 100 | In distribution | |
| T220GR | 100 | In distribution | |
| S221YL | 100 | In distribution | |
| M222SA | 100 | In distribution | |
| T220LM | 100 | In distribution | |
| T-M222GR | 100 | In distribution | |
| 220-DB | 100 | In distribution | |
| 220-GR | 100 | In distribution | |
| T-M222DB | 100 | In distribution | |
| T220YL | 100 | In distribution | |
| T221OR | 100 | In distribution | |
| S221PK | 100 | In distribution | |
| T221GR | 100 | In distribution | |
| S221OR | 100 | In distribution | |
| S221WT | 100 | In distribution | |
| T-M222YL | 100 | In distribution | |
| T-M222WT | 100 | In distribution | |
| 221-RD | 100 | In distribution | |
| 220-OR | 100 | In distribution | |
| 220-SA | 100 | In distribution | |
| T-M222SA | 100 | In distribution | |
| T-P222XA | 100 | In distribution | |
| T-M222LM | 100 | In distribution | |
| M222OR | 100 | In distribution | |
| P222RD | 100 | In distribution | |
| M222YL | 100 | In distribution | |
| T-P222LM | 100 | In distribution | |
| T221PK | 100 | In distribution | |
| M222GR | 100 | In distribution | |
| T221XA | 100 | In distribution | |
| T-M222PK | 100 | In distribution | |
| T-P222DB | 100 | In distribution | |
| 220-LB | 100 | In distribution | |
| P222DB | 100 | In distribution | |
| 221-GR | 100 | In distribution | |
| M222RA | 100 | In distribution | |
| S221RD | 100 | In distribution | |
| T221WT | 100 | In distribution | |
| S221RA | 100 | In distribution | |
| P222PK | 100 | In distribution | |
| 220-LM | 100 | In distribution | |
| S221LB | 100 | In distribution | |
| T-P222PK | 100 | In distribution | |
| T-P222YL | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AllPro | Team Technologies, Inc. | 111 |
| Young | Young Dental Manufacturing I, LLC | 75 |
| SKY Choice | Hexa Dental | 23 |
| Ultrapro Tx | Ultradent Products Inc. | 22 |
| JMU | JMU Dental, Inc | 21 |
| Prophy Brushes | TDV Dental Ltda | 21 |
| Henry Schein | Henry Schein, Inc. | 20 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 18 |
| Prophy Rubber Cup | Diadent Group Intl., Inc. | 12 |
| 2PRO | Premier Dental Products Co. | 11 |
| Hexa | Hexa Dental | 9 |
| Dream by 3D Dental | 3D Dental Designs AND Development, LLC | 9 |
Showing 12 of 71. All products under Cup, Prophylaxis
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.