Surgical Straight Handpiece
The SGS-E2S Surgical Straight Handpiece drives rotary burs for oral surgical and dental procedures performed by licensed professionals. Its applications include cutting teeth, removing or…
The SGS-E2S Surgical Straight Handpiece drives rotary burs for oral surgical and dental procedures performed by licensed professionals. Its applications include cutting teeth, removing or shaping bone, root tip surgery and drilling the upper or lower jaw during implant treatment. It attaches to a compatible air motor or electric micromotor.
The straight handpiece uses a speed increasing gear arrangement and a locking ring chuck to hold the bur. It has an external irrigation nozzle and is supplied without optical illumination. Motor coupling and bur compatibility follow the specified ISO connection and bur standards.
Processing
The handpiece is supplied nonsterile and requires steam sterilization before its first use and after subsequent uses. Its construction includes stainless steel and aluminium, with stainless steel water lines.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
Record
| Listed by | Nakanishi Inc., Japan |
|---|---|
| FDA product code | KMW |
| Device type | Handpiece, Rotary Bone Cutting |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K171155 |
| Record published | 2018-01-22 |
| Record revised | 2023-10-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SGS-E2S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 297 |
| Ti-Max X | Nakanishi Inc. | 19 |
| Micro Surgery Handpiece | Nakanishi Inc. | 4 |
| Turning Handle | W&H Dentalwerk Bürmoos GmbH | 4 |
| SGM-ER32i | Nakanishi Inc. | 3 |
| Ti-Max | Nakanishi Inc. | 3 |
| SM3 | Osstem Implant Co., Ltd._Gasan Branch | 3 |
| SGQ-H | Nakanishi Inc. | 3 |
| Sgms-I | Nakanishi Inc. | 2 |
| S-Max M | Nakanishi Inc. | 2 |
| SGM-I | Nakanishi Inc. | 2 |
| SGM-ER16i | Nakanishi Inc. | 2 |
Showing 12 of 93. All products under Handpiece, Rotary Bone Cutting
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211584 | 2021-08-19 |
| K171155 | 2017-11-21 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products | 12 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products | 0 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products | 18 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products m | 6 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products m | 2419 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products m | 1662 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products m | 440 | 2021-04-28 |
| Nakanishi Inc. | 510(k) number | 2018-06-01 | Class II | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products m | 1878 | 2021-04-28 |
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.