Brasseler USA
Irrigation Needles 31GA 21MM
56manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (12), Jiangsu (11), Guangdong (9). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| 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 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Ningbo Caremed Medical Products Co Ltd | Ningbo | Zhejiang | Contract manufacturer | 6 |
| China Zhong YAN Chang Xing International Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 56. All 56 manufacturers in China registered for Needle, Dental
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | DZM |
| Device type | Needle, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4730 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2023-08-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5001851U0 | In distribution | |
| 5026680U0 | In distribution | |
| 5025451U0 | In distribution | |
| 5026557U0 | In distribution | |
| 5001850U0 | In distribution | |
| 5026558U0 | In distribution | |
| 5026681U0 | In distribution | |
| 5025827U0 | In distribution | |
| 5001638U0 | In distribution | |
| 5001769U0 | In distribution | |
| 5025473U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kohdent | Kohler Medizintechnik GmbH | 47 |
| Ultrasonic Scaler Tips | Guilin Veirun Medical Technology Co., Ltd. | 38 |
| Henry Schein | Henry Schein, Inc. | 32 |
| Plasdent | Plasdent Corp. | 30 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 20 |
| Benco | Benco Dental Supply Co. | 20 |
| Monoject | Cardinal Health | 12 |
| Monoject | Cardinal Health 200, LLC | 12 |
| Pressure Syringe Needles | Pulpdent Corporation | 12 |
| Needle, Dental | medmix Deutschland GmbH | 9 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 9 |
| V-Ject | Vericom Co., Ltd. | 8 |
Showing 12 of 97. All products under Needle, 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.