The Wand STA Handpiece
STA Handpiece without needle
3manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
1recall
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 | Milestone Scientific, Inc., United States |
|---|---|
| FDA product code | EJI |
| Device type | Syringe, Cartridge |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6770 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K061904 |
| Record published | 2018-01-26 |
| Record revised | 2022-12-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| STA-5050-2725 | 600 | In distribution | |
| STA-5050-301 | 600 | In distribution | |
| STA-5050-305 | 600 | In distribution | |
| STA-5050A | 50 | In distribution | |
| STA-5050-2725 | 50 | In distribution | |
| STA-5050-305 | 50 | In distribution | |
| STA-5050-301 | 50 | In distribution | |
| STA-5050A | 600 | 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 Handpiece | Milestone Scientific, Inc. | 8 |
| Saftey Wand STA Handpiece | Milestone Scientific, Inc. | 7 |
| J&J Instruments | J & J Instruments, LLC | 6 |
| Patterson | Patterson Dental Supply, Inc. | 4 |
Showing 12 of 88. All products under Syringe, Cartridge
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061904 | 2006-08-08 |
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.