Instruments, Dental Hand
Sterile Suction Needles (Endo Evacuation Needles) are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site during oral surgery. The device is…
Sterile Suction Needles (Endo Evacuation Needles) are used for suction in intraoral areas with difficult access, such as root canal, or in a surgical site during oral surgery. The device is a semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, irrigating solutions and water during a dental or oral procedure. Suction Needles are to be locked on a Luer Lock connection. It is not intended to penetrate tissue (it is not an injection needle). The cannula is made of stainless steel. This is a single-use device.
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (10), Hebei (5). 8 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| 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 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| medmix China Ltd | Shanghai | Shanghai | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
Showing 12 of 64. All 64 manufacturers in China registered for Instruments, Dental Hand
Record
| Listed by | medmix Deutschland GmbH, Germany |
|---|---|
| FDA product code | DZN |
| Device type | Instruments, Dental Hand |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-26 |
| Record revised | 2024-10-01 (version 3) |
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 |
| Distribution end date | 2024-10-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 23G 0.6 x 25 mm, Luer Lock, double side vent, closed end, in sheath, blue | 40 | In distribution | |
| 18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub purple | 100 | In distribution | |
| 20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub yellow | 100 | In distribution | |
| 27G 0.4 x 25 mm, Luer Lock, double side vent, closed end, in sheath, medium grey | 40 | In distribution | |
| 25G 0.5 x 25 mm, Luer Lock, double side vent, closed end, in sheath, orange | 40 | In distribution | |
| 30G 0.3 x 32 mm, Luer Lock, single apical side vent, in sheath, hub yellow | 25 | In distribution | |
| 30G 0.3 x 25 mm, Luer Lock, double side vent, closed end, in sheath, yellow | 40 | In distribution | |
| 16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub white | 100 | In distribution | |
| 14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub green | 100 | In distribution | |
| 27G 0.4 x 32 mm, Luer Lock, single apical side vent, in sheath, hub medium grey | 25 | In distribution | |
| 16G 1.6 x 39 mm, Luer Lock, blunt, in blister, hub white | 100 | Withdrawn | |
| 18G 1.2 x 39 mm, Luer Lock, blunt, in blister, hub purple | 100 | Withdrawn | |
| 14G 2.1 x 39 mm, Luer Lock, blunt, in blister, hub green | 100 | Withdrawn | |
| 20G 0.9 x 39 mm, Luer Lock, blunt, in blister, hub yellow | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMDental | LM-Dental | 936 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 544 |
| Instruments, Dental Hand | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 307 |
| Power Dental USA | Power Dental U.S.A. Inc. | 209 |
| Supremo Instrumentos | Andre Gregate Braga Instrumentos Ltda | 95 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 92 |
| Diamodent | Diamodent | 81 |
| Stoma® | Storz AM Mark Gmbh | 80 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 77 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 67 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 58 |
Showing 12 of 1,362. All products under Instruments, Dental Hand
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.