S-Guide Kit
Keyless, precise, open guided surgery kit, designed to allow for more accurate, efficient and safe surgery with minimal error and drill heating.
29manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (6), Shanghai (3). 6 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 |
| 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 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Instrument, Dental
Record
| Listed by | Shinhung MST Co., Ltd., South Korea |
|---|---|
| FDA product code | EJB |
| Device type | Handle, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-13 |
| Record revised | 2022-06-17 (version 3) |
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, manufacturing date |
| Storage | Storage environment temperature 1 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ADH10 | In distribution | |
| FMW | In distribution | |
| FDMH | In distribution | |
| TP50W | In distribution | |
| TP45 | In distribution | |
| GS50 | In distribution | |
| FDRH | In distribution | |
| NMDM | In distribution | |
| HGS57 | In distribution | |
| DE10 | In distribution | |
| SSGR50C | In distribution | |
| SSGR57C | In distribution | |
| ASS | In distribution | |
| NMDW | In distribution | |
| TP35 | In distribution | |
| FMM | In distribution | |
| FMR | In distribution | |
| HGS50 | In distribution | |
| GS57 | In distribution | |
| FDWH | In distribution | |
| ASL | In distribution | |
| TP40W | In distribution | |
| SGK | In distribution | |
| NMDR | In distribution | |
| SSGW50C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 121 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 89 |
| Premium Plus | Premium Plus International Limited | 83 |
| Surgical Kit | Shinhung MST Co., Ltd. | 78 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 59 |
| Bioclear Diamond Wedge | Bioclear Matrix Systems, LLC | 50 |
| Hygitech | Hygitech | 47 |
| Plasdent | Plasdent Corp. | 37 |
| Stoma® | Storz AM Mark Gmbh | 34 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 34 |
| LMDental | LM-Dental | 33 |
| Henry Schein | Henry Schein, Inc. | 32 |
Showing 12 of 221. All products under Handle, Instrument, 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.