CompuDent STA
STA Instrument
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
Record
| Listed by | Tricor Systems, United States |
|---|---|
| FDA product code | EJI |
| Device type | Syringe, Cartridge |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6770 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K061904 |
| Record published | 2018-01-26 |
| Record revised | 2020-07-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| STA-5110 | 4 | In distribution | |
| STA-5110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Septodont | A. Titan Instruments, Inc. | 51 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 46 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| Astek | Young Innovations Inc. | 34 |
| Artman Instruments | Wise Linkers LLC | 16 |
| Osung MND | Osung MND Co., Ltd. | 11 |
| Safety Wand Handpiece | Milestone Scientific, Inc. | 8 |
| Henke-Dent 500 Soft-Grip | Henke-Sass Wolf, Gmbh. | 8 |
| the Wand STA Handpiece | Milestone Scientific, Inc. | 8 |
| the Wand Handpiece | Milestone Scientific, Inc. | 8 |
| Saftey Wand STA Handpiece | Milestone Scientific, Inc. | 7 |
| J&J Instruments | J & J Instruments, LLC | 6 |
Showing 12 of 88. All products under Syringe, Cartridge
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Milestone Scientific, Inc. | 510(k) number | 2015-02-11 | Class III | Nonconforming Material/Component | Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument. | 165,850 units | 2016-09-20 |
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.