Gentle Hand-Bur Systems
P2: A “P2” dental hand-bur handle, is a "premium" locking-handle which consists of a round, threaded, aluminum handle which embodies a heavy-duty micro-chuck assembly (MCA). The MCA…
P2: A “P2” dental hand-bur handle, is a “premium” locking-handle which consists of a round, threaded, aluminum handle which embodies a heavy-duty micro-chuck assembly (MCA). The MCA embodies a threaded end which screws into the handle’s internal threads in order to secure a dental bur so it cannot dislodge while in use. To secure a dental bur after insertion, a bur-locking-wrench grips the MCA and is counter-tightened by a locking pin at the handle’s opposite end. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The casing is made of durable, 2 mm 6061-T6 medical grade aluminum designed for maximum strength and longevity. Rightly classed as a “premium” model, it can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. Learn more about our mission at dentalcareforall.org. If you have any complaints with our products please call or email us for immediate resolution: email team@dcfai.org / Call +19562801708 (WhatsApp)
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 | Dental Care FOR ALL International |
|---|---|
| FDA product code | DZN |
| Device type | Instruments, Dental Hand |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-07-09 |
| Record revised | 2024-10-04 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Distribution end date | 2022-10-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P4 | 4 | In distribution | |
| C4 | 4 | In distribution | |
| P2 | 2 | In distribution | |
| KC | 8 | In distribution | |
| E1 | In distribution | ||
| P1 | 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.