Sirona
X-Ray Sensor Sheaths, Sirona Sensor (1) Sheaths
40manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Shanghai (8), Jiangsu (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 |
| Tianchang Jiarui Packaging Material Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| Trelleborg Sealing Solutions Suzhou Company Limited | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Wenzhou Wapro Technology Co Ltd | Longgang | Zhejiang | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| 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 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
Showing 12 of 40. All 40 manufacturers in China registered for Holder, Film, X-Ray
Record
| Listed by | Tidi Products, LLC, United States |
|---|---|
| FDA product code | EGZ |
| Device type | Holder, Film, X-Ray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.1905 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-07 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 5000, box of 300 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20904 | In distribution | |
| 6409960 | In distribution | |
| 6409952 | In distribution | |
| 20890 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrollByte | Directa AB | 181 |
| Rinn® | Dentsply LLC | 87 |
| Cefla | Duphamed B.V. | 24 |
| Techno-Aide | Techno-Aide, Inc. | 23 |
| DenBite | Duphamed B.V. | 20 |
| Steri-Shield | Steri-Shield Products, Inc. | 19 |
| Henry Schein | Henry Schein, Inc. | 19 |
| Plasdent | Plasdent Corp. | 16 |
| Visionary by 3D Dental | 3D Dental Designs AND Development, LLC | 16 |
| Essentials by 3D Dental | 3D Dental Designs AND Development, LLC | 15 |
| Care Stream Dental | Duphamed B.V. | 14 |
| JMU | JMU Dental, Inc | 13 |
Showing 12 of 204. All products under Holder, Film, X-Ray
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.