SGT2-E
Catalogue number SGT2-E, listed by Nakanishi Inc., Japan, under Handpiece, Rotary Bone Cutting. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
8recalls on this code
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 |
| Record published | 2016-09-16 |
| Record revised | 2021-10-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2021-08-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SGT2-E | Withdrawn |
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
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.