CA160L
The FDA filing describes the CA160, CA160L and CA500L models as dental handpieces for general dentistry. Their stated uses include removing carious material, reducing hard tooth structure,…
The FDA filing describes the CA160, CA160L and CA500L models as dental handpieces for general dentistry. Their stated uses include removing carious material, reducing hard tooth structure, and preparing cavities, crowns and root canals.
The handpieces are also described for removing fillings, processing and finishing tooth preparations and restorations, and polishing teeth. The filing specifies that they are designed for use by a trained dental professional.
Listed Model
The filing’s proposed-device description specifically includes CA160L among the subject dental handpiece models.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Micro-NX Co., Ltd., South Korea |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Manufacturer |
| 510(k) | K220577 |
| Record published | 2026-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CA160L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 366 |
| Young | Young Dental Manufacturing I, LLC | 94 |
| Henry Schein | Henry Schein, Inc. | 84 |
| StarDental Instrument Solutions | Dentalez, Inc. | 63 |
| Maxso | Beyes Dental Canada, Inc. | 42 |
| Nupro® | Dentsply Professional | 35 |
| AllPro | Team Technologies, Inc. | 30 |
| Medidenta | Medidenta | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 23 |
| Maxima | Henry Schein, Inc. | 21 |
| Denticator | Young Dental Manufacturing I, LLC | 19 |
| Henry Schein | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 247. All products under Handpiece, Contra- And Right-Angle Attachment, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220577 | 2022-07-29 |
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.