Needle, Dental
Sterile Single-Use Dental Injection Needles are sterile, disposable, sharp bevel-edged, hollow tubular metal instruments with an integrated hub. Sterile Single-Use Dental Injection Needles…
Sterile Single-Use Dental Injection Needles are sterile, disposable, sharp bevel-edged, hollow tubular metal instruments with an integrated hub. Sterile Single-Use Dental Injection Needles should be used in combination with dental cartridge syringes (according to ISO 9997) in which a dental cylinder ampoule according to ISO 11040-1 is inserted.
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 | medmix Deutschland GmbH, Germany |
|---|---|
| FDA product code | DZM |
| Device type | Needle, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4730 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 25G 0.5 x 35 mm, long, RW (regular wall), hub and front cap red | 100 | In distribution | |
| 30G 0.3 x 13 mm, short, RW (regular wall), hub dark blue and front cap blue | 100 | In distribution | |
| 27G 0.4 x 35 mm, long, RW (regular wall), hub and front cap yellow | 100 | In distribution | |
| 27G 0.4 x 25 mm, short, RW (regular wall), hub and front cap yellow | 100 | In distribution | |
| 27G 0.4 x 35 mm, long, RW (regular wall), hub and front cap yellow | 100 | In distribution | |
| 27G 0.4 x 25 mm, short, RW (regular wall), hub and front cap yellow | 100 | In distribution | |
| 30G 0.3 x 25 mm, short, RW (regular wall), hub dark blue and front cap blue | 100 | In distribution | |
| 30G 0.3 x 25 mm, short, RW (regular wall), hub dark blue and front cap blue | 100 | In distribution | |
| 25G 0.5 x 25 mm, short, RW (regular wall), hub and front cap red | 100 | 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 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 11 |
| 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.