StarDental Instrument Solutions
Star 400 Flex Handpiece, Lubricated, non-Fiber Optic
10manufacturers in China registered for this device type
47catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Guangxi (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Sinol Dental Limited | Xianyang | Shaanxi | Manufacturer | 5 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Litu Tech Ltd. | Zhongshan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Dentalez, Inc., United States |
|---|---|
| FDA product code | EFB |
| Device type | Handpiece, Air-Powered, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| 510(k) | K153411 |
| Record published | 2018-11-05 |
| Record revised | 2025-06-23 (version 4) |
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, serial number |
| Distribution end date | 2025-06-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 264951 | In distribution | |
| 268841 | In distribution | |
| 265891 | In distribution | |
| 266183 | In distribution | |
| 268861 | In distribution | |
| 265890 | In distribution | |
| 265630 | In distribution | |
| 268860 | In distribution | |
| 264952 | In distribution | |
| 266213 | In distribution | |
| 268843 | In distribution | |
| 265821 | In distribution | |
| 265138 | In distribution | |
| 265892 | In distribution | |
| 266154 | In distribution | |
| 263758 | In distribution | |
| 266281 | In distribution | |
| 262052 | In distribution | |
| 264450 | In distribution | |
| 265232 | In distribution | |
| 263773 | In distribution | |
| 266276 | In distribution | |
| 266182 | In distribution | |
| 266212 | In distribution | |
| 262057ASPEN | In distribution | |
| 266260 | In distribution | |
| 265400 | In distribution | |
| 265634 | In distribution | |
| 264451 | In distribution | |
| 265822 | In distribution | |
| 264422 | In distribution | |
| 266275 | In distribution | |
| 268840 | In distribution | |
| 266245 | In distribution | |
| 263772 | In distribution | |
| 266153 | In distribution | |
| 265646 | In distribution | |
| 262057 | In distribution | |
| 265718 | Withdrawn | |
| 265718G | Withdrawn | |
| 265721 | Withdrawn | |
| 265718Y | Withdrawn | |
| 268844 | Withdrawn | |
| 263996 | Withdrawn | |
| 265633 | Withdrawn | |
| 265718F | Withdrawn | |
| 265791 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AIR-Flow | E.M.S. Electro Medical Systems S.A. | 220 |
| Lares Research | Lares Research | 130 |
| MK-dent | MK-dent GmbH | 129 |
| Vector R&D, Inc | Vector R&D, Inc. | 114 |
| MK-dent Germany® | MK-dent GmbH | 112 |
| Johnson-Promident | Young Innovations Inc. | 92 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 76 |
| Airlight | Beyes Dental Canada, Inc. | 65 |
| Henry Schein | Henry Schein, Inc. | 62 |
| MicroP Dental | Microp Technology (Taiwan), Inc. | 51 |
| Air-Driven Dental Handpieces | MDK Co., Ltd. | 39 |
| Maxso | Beyes Dental Canada, Inc. | 38 |
Showing 12 of 968. All products under Handpiece, Air-Powered, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192412 | 2020-01-06 |
| K173465 | 2018-03-28 |
| K153411 | 2016-04-08 |
| K113301 | 2012-01-23 |
| K093072 | 2009-12-28 |
| K070869 | 2007-06-15 |
| K982593 | 1998-10-22 |
| K896361 | 1990-02-02 |
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.