Helmut Zepf
CUP, Prophylaxis, Stainless Steel, Plastic LID, Diam. 40 MM X 25 MM High (Usable ON Both Sides)
49manufacturers in China registered for this device type
8catalogue 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 | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EHK |
| Device type | Cup, Prophylaxis |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6290 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-09 |
| Record revised | 2023-12-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 85.251.03 | In distribution | |
| 85.251.04 | In distribution | |
| 85.251.10 | In distribution | |
| 85.252.25 | In distribution | |
| 85.255.02 | In distribution | |
| 85.264.350 | In distribution | |
| 85.251.14 | In distribution | |
| 85.252.140 | 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
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.