Airlight
The FDA filing describes the Airlight Dental Handpiece as a high-speed dental handpiece with a lightly textured finish. It is a handheld, channeled instrument powered by compressed air…
The FDA filing describes the Airlight Dental Handpiece as a high-speed dental handpiece with a lightly textured finish.
It is a handheld, channeled instrument powered by compressed air delivered through a hose to an air channel in the handpiece.
Listed Item
“M800P-M/PD/NS, PLUS , Single Stream, Non-Spray, Safeguard Air Technology Available”
Device Description and Stated Use
The stated uses include removing carious material, reducing hard tooth structure, preparing cavities, finishing tooth preparations and restorations, and polishing teeth. The filing also states it is handheld.
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 | Beyes Dental Canada, Inc., United States |
|---|---|
| FDA product code | EFB |
| Device type | Handpiece, Air-Powered, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| 510(k) | K112623 |
| Record published | 2023-05-11 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HP3054P | In distribution | |
| HP3042P | In distribution | |
| HP3015P | In distribution | |
| HP3057 | In distribution | |
| HP3044 | In distribution | |
| HP3054 | In distribution | |
| HP6018X | In distribution | |
| HP3052 | In distribution | |
| HP3043P | In distribution | |
| HP3056 | In distribution | |
| HP3021P | In distribution | |
| HP3055 | In distribution | |
| HP3015P | In distribution | |
| HP3036P | In distribution | |
| HP3042P | In distribution | |
| HP3055 | In distribution | |
| HP6038 | In distribution | |
| HP3054X | In distribution | |
| HP3043X | In distribution | |
| HP3052 | In distribution | |
| HP3022 | In distribution | |
| HP3051 | In distribution | |
| HP3035P | In distribution | |
| VHP3008P | In distribution | |
| HP3037 | In distribution | |
| HP3036 | In distribution | |
| HP3043X | In distribution | |
| HP3015 | In distribution | |
| HP3037 | In distribution | |
| HP3036X | In distribution | |
| HP3056 | In distribution | |
| HP6028P | In distribution | |
| HP3036 | In distribution | |
| HP3043 | In distribution | |
| HP3022P | In distribution | |
| HP3022P | In distribution | |
| HP6028P | In distribution | |
| HP3036P | In distribution | |
| HP6018 | In distribution | |
| HP3014P | In distribution | |
| HP6018 | In distribution | |
| HP3014P | In distribution | |
| HP3048 | In distribution | |
| HP6018P | In distribution | |
| HP3054X | In distribution | |
| HP6018X | In distribution | |
| VHP3008P | In distribution | |
| HP3044 | In distribution | |
| HP3043 | In distribution | |
| HP3022 | In distribution | |
| HP3008 | In distribution | |
| HP3048 | In distribution | |
| HP6038 | In distribution | |
| HP3051 | In distribution | |
| HP3043P | In distribution | |
| HP3054 | In distribution | |
| HP6018P | In distribution | |
| HP3035P | In distribution | |
| HP3008P | In distribution | |
| HP3054P | In distribution | |
| HP3008 | In distribution | |
| HP3057 | In distribution | |
| HP3008P | In distribution | |
| HP3036X | In distribution | |
| HP3021P | 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 |
| 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 |
|---|---|
| K112623 | 2011-12-16 |
| K112869 | 2011-12-16 |
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.