Dash
DASH Tooth Whitening Procedure Kit
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Hangzhou Yunchi Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Discus Dental, LLC, United States |
|---|---|
| FDA product code | OGT |
| Device type | Oral Irrigation Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6510 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K062176 |
| Record published | 2016-09-07 |
| Record revised | 2024-08-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2016-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DIS429/01 | Withdrawn |
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.