FlexiCup Medium
Catalogue number 403101, listed by Cosmedent, Inc., United States, under Cup, Prophylaxis. 49 manufacturers in China are registered for this product code.
49manufacturers in China registered for this device type
1catalogue number
1recall
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 | Cosmedent, Inc., United States |
|---|---|
| FDA product code | EHK |
| Device type | Cup, Prophylaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6290 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-01-22 |
| Record revised | 2020-05-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 403101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 115 |
| 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 |
Showing 12 of 71. All products under Cup, Prophylaxis
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cosmedent, Inc. | UDI-DI | 2023-07-20 | Class II | Under Investigation by firm | Reports were received the elastomer cup material is crumbling. | 7,400 packs of 6 |
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.