Pana Spray Plus
PANA SPRAY Plus is an aerosol cleaner and lubricant for routine maintenance of dental and medical surgical handpieces. It is used after each patient and before sterilization. The alcohol…
PANA SPRAY Plus is an aerosol cleaner and lubricant for routine maintenance of dental and medical surgical handpieces. It is used after each patient and before sterilization. The alcohol based formulation supports cleaning and lubrication of high speed and low speed handpieces and air motors.
The spray is introduced through the handpiece’s air drive pipe or rear connection, distributing the maintenance fluid into the instrument. Its formulation contains lubricant and alcohol components with a propellant that delivers the material from the aerosol container.
Presentation
The product is supplied in 480 mL aerosol cans for prescription use. Cleaning and lubrication form part of the handpiece maintenance sequence before the instrument undergoes its specified sterilization process.
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 | Nakanishi Inc., Japan |
|---|---|
| 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) | K163483 |
| Record published | 2025-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PANA SPRAY Plus | In distribution | |
| PANA SPRAY Plus | 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 |
| 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 |
| StarDental Instrument Solutions | Dentalez, Inc. | 47 |
| Air-Driven Dental Handpieces | MDK Co., Ltd. | 39 |
Showing 12 of 968. All products under Handpiece, Air-Powered, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241880 | 2024-09-20 |
| K233308 | 2024-04-25 |
| K230888 | 2023-06-02 |
| K203791 | 2022-06-21 |
| K163483 | 2017-08-15 |
| K112024 | 2012-06-20 |
| K113655 | 2012-03-05 |
| K112673 | 2012-02-07 |
| K081811 | 2009-01-21 |
| K032395 | 2003-10-17 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-07-08 | Class II | Error in labeling | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are | 4284 units | 2018-06-25 |
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.