Henry Schein
Endo Cassette 1 w/Sterimeter
37manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (5), Zhejiang (5). 8 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
Showing 12 of 37. All 37 manufacturers in China registered for Accessories, Retractor, Dental
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EIF |
| Device type | Accessories, Retractor, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2017-03-30 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5700417 | In distribution | |
| 5700421 | In distribution | |
| 5700418 | In distribution | |
| 1025525 | In distribution | |
| 5700419 | In distribution | |
| 5700420 | In distribution | |
| 1023896 | In distribution | |
| 1026657 | In distribution | |
| 9001251 | In distribution | |
| 5700423 | In distribution | |
| 9004786 | In distribution | |
| 9001252 | In distribution | |
| 5700426 | In distribution | |
| 1026303 | In distribution | |
| 5700427 | In distribution | |
| 5700416 | In distribution | |
| 5700424 | In distribution | |
| 5700425 | In distribution | |
| 5700422 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfit OneML | Vatech mcis Co., Ltd. | 121 |
| Perfit ZR | Vatech mcis Co., Ltd. | 108 |
| OSE | Orthodontic Supply & Equipment Co., Inc. | 36 |
| Sure-endo | Sure Dent Corporation | 24 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 23 |
| Kohdent | Kohler Medizintechnik GmbH | 19 |
| House Brand Dentistry | Frontier Dental Supply Inc | 16 |
| PrimeLoc | IPB Inc | 14 |
| Dentech | Dentech Corp. | 12 |
| Ceka & Preci-Line Attachments | Alphadent Co., Ltd. | 10 |
| Intraoral Cheek Retractors | Ortho Technology, Inc. | 9 |
| DCI | DCI International, LLC | 7 |
Showing 12 of 152. All products under Accessories, Retractor, 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.