Genesis Active
Genesis Active Conical Ø1.25 Hex Prosthetic Screwdriver, Manual, Medium, 14mm
64manufacturers in China registered for this device type
25catalogue numbers in this listing
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 | Keystone Dental Inc., United States |
|---|---|
| FDA product code | DZN |
| Device type | Instruments, Dental Hand |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-19 |
| Record revised | 2023-09-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 9 to 34 mm; outer diameter 4.1 to 5.8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GA71527 | 1.25 Hex | In distribution |
| GA71108 | Outer Diameter 5.8 mm | In distribution |
| GA71105 | Outer Diameter 4.1 mm | In distribution |
| GA71109 | Outer Diameter 5.8 mm | In distribution |
| GA51003 | Outer Diameter 5.8 mm | In distribution |
| GA71532 | 1.25 Hex | In distribution |
| GA71637 | Length 20 mm | In distribution |
| GA71106 | Outer Diameter 5.1 mm | In distribution |
| GA31000 | Length 34 mm | In distribution |
| GA31003 | Length 20 mm | In distribution |
| G71710 | In distribution | |
| GA71526 | Length 23 mm | In distribution |
| GA71534 | Length 9 mm | In distribution |
| GA71107 | Outer Diameter 5.1 mm | In distribution |
| GA71533 | Length 14 mm | In distribution |
| GA71104 | Outer Diameter 4.1 mm | In distribution |
| GA71528 | Length 9 mm | In distribution |
| GA31002 | Length 25 mm | In distribution |
| GA71529 | Length 23 mm | In distribution |
| GA71531 | Length 9 mm | In distribution |
| GA71638 | Length 24 mm | In distribution |
| GA51001 | Outer Diameter 4.1 mm | In distribution |
| GA51002 | Outer Diameter 5.1 mm | In distribution |
| GA71530 | 1.25 Hex | In distribution |
| GA31001 | Length 29 mm | In distribution |
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.