Dukal
Digital X-Ray Sensor Sleeve, 2-1/2" x 10"
65manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (15), Shanghai (9), Hebei (8). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Yangzhou Star Oral Care Product Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 7 |
| Dacheng Huaguan Dental Instruments Co., Ltd. | Langfang | Hebei | Contract manufacturer | 4 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
Showing 12 of 65. All 65 manufacturers in China registered for Unit, Operative Dental, Accessories
Record
| Listed by | Dukal LLC, United States |
|---|---|
| FDA product code | NRD |
| Device type | Unit, Operative Dental, Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-06 |
| Record revised | 2026-07-15 (version 5) |
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 |
| Packaging | Case of 36, case of 6, case of 12 |
| Distribution end date | 2029-06-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 27613 | 500 | In distribution | |
| 27614 | 500 | In distribution | |
| 27608 | 500 | In distribution | |
| 27610 | 500 | In distribution | |
| 27604 | Withdrawn | ||
| 27609 | 500 | Withdrawn | |
| 27612 | 500 | Withdrawn | |
| 27605 | Withdrawn | ||
| 27611 | 500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plasdent | Plasdent Corp. | 409 |
| Midmark | Midmark Corporation | 106 |
| BaseVac | R.E. Morrison Equipment Inc | 70 |
| Unipack | Unipack LLC | 51 |
| Mojave | AIR Techniques, Inc. | 50 |
| AirStar | AIR Techniques, Inc. | 48 |
| Premium Plus | Premium Plus International Limited | 47 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 38 |
| Benco | Benco Dental Supply Co. | 37 |
| Ramvac | Dentalez Alabama, Inc. | 32 |
| VacStar | AIR Techniques, Inc. | 29 |
| Safe Dent | Bgss Company Inc | 22 |
Showing 12 of 107. All products under Unit, Operative Dental, Accessories
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.