MK-dent
Contra Angle Prophy Handpiece
10manufacturers in China registered for this device type
129catalogue numbers in this listing
2510(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 | MK-dent GmbH, Germany |
|---|---|
| FDA product code | EFB |
| Device type | Handpiece, Air-Powered, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K032234 |
| Record published | 2024-10-14 |
| Record revised | 2024-10-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature up to 50 °C; Storage environment temperature up to 122 °F; Handling environment temperature up to 50 °C; Handling environment temperature up to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
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| ACCESSORIES | In distribution | |
| PREMIUM SERVICE OIL | In distribution | |
| CLASSIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| PREMIUM SERVICE OIL | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| PRIME LINE | In distribution | |
| BASIC LINE | In distribution | |
| ACCESSORIES | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| PRIME LINE | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| CLASSIC LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ACCESSORIES | In distribution | |
| PRIME LINE | In distribution | |
| PRIME LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ACCESSORIES | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| BASIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| CLASSIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| PRIME LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| ACCESSORIES | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| PRIME LINE | In distribution | |
| ACCESSORIES | In distribution | |
| PRIME LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| ACCESSORIES | In distribution | |
| CLASSIC LINE | In distribution | |
| BASIC LINE | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ACCESSORIES | In distribution | |
| BASIC LINE | In distribution | |
| SERVICE OIL | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| PRIME LINE | In distribution | |
| BASIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| PRIME LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ACCESSORIES | In distribution | |
| ACCESSORIES | In distribution | |
| PRIME LINE | In distribution | |
| PRIME LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| ECO LINE | In distribution | |
| ACCESSORIES | In distribution | |
| ECO LINE | In distribution | |
| CLASSIC LINE | In distribution | |
| ECO LINE | In distribution | |
| BASIC LINE | In distribution | |
| ACCESSORIES | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AIR-Flow | E.M.S. Electro Medical Systems S.A. | 220 |
| Lares Research | Lares Research | 130 |
| 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 |
| StarDental Instrument Solutions | Dentalez, Inc. | 47 |
| 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 |
|---|---|
| K051872 | 2005-10-03 |
| K032234 | 2003-10-02 |
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.