Beyes
Universal Sensor Holder Starter kit include:Positioning Arm Posterior x1,Positioning Arm Bite Wing x1,Positioning Arm Anterior x1,Bite Block Size #2 x1,Bite Block Size #1 x1,Posterior…
Universal Sensor Holder Starter kit include:Positioning Arm Posterior x1,Positioning Arm Bite Wing x1,Positioning Arm Anterior x1,Bite Block Size #2 x1,Bite Block Size #1 x1,Posterior Aiming Ring x1,Anterior/Bite Wing Aiming Ring x1
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shanghai Handy Medical Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Beyes Dental Canada, Inc., United States |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K212279 |
| Record published | 2023-04-28 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS1103 | In distribution | |
| DS1108 | In distribution | |
| DS1110 | In distribution | |
| DS1106 | In distribution | |
| DS1107 | In distribution | |
| DS1109 | In distribution | |
| DS1104 | In distribution | |
| DS1105 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Schick Elite | Sirona Dental, Inc. | 38 |
| Schick Wifi | Sirona Dental, Inc. | 31 |
| Midmark Intraoral Digital Sensor | Midmark Corporation | 26 |
| Xios XG Wifi | Sirona Dental, Inc. | 25 |
| Midmark OptiMax Digital Sensor System | Midmark Corporation | 24 |
| Gendex GXS-700™ intraoral sensor | Gendex Corp. | 19 |
| Genoray | Genoray Co., Ltd. | 14 |
| X-Mind trium | DE Götzen SRL | 12 |
| X-Mind optima 3D | DE Götzen SRL | 12 |
| Dexis Titanium Sensor Kit | Dental Imaging Technologies Corporation | 11 |
| Xios XG Select | Sirona Dental, Inc. | 11 |
| Planmeca ProMax | Planmeca Oy | 11 |
Showing 12 of 279. All products under System, X-Ray, Extraoral Source, Digital
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.