Premium Plus
Fluoride Trays
22manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (4), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| China Zhong YAN Chang Xing International Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
Showing 12 of 22. All 22 manufacturers in China registered for Tray, Fluoride, Disposable
Record
| Listed by | Premium Plus (Dongguan) Limited, China |
|---|---|
| FDA product code | KMT |
| Device type | Tray, Fluoride, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6870 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7800M | 50 | In distribution | |
| 7800S | 50 | In distribution | |
| 7801L | 100 | In distribution | |
| 7801S | 100 | In distribution | |
| 7801M | 100 | In distribution | |
| 7800L | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 11 |
| Topex® | Sultan Healthcare Inc | 7 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 7 |
| Health-Tec/DHP Fluoride Trays | Dental Health Products Inc | 7 |
| Young | Young Dental Manufacturing I, LLC | 6 |
| Medicom Denticare PRO-Tray | AMD Medicom Inc. | 6 |
| Safco Fluora Trays | Safco Dental Supply | 5 |
| Discovery Tray | Kerr Corporation | 4 |
| Nupro® | Dentsply Professional | 4 |
| Zap™ Dual Arch Fluoride Gel Trays | Crosstex International | 3 |
| Safe Dent | Bgss Company Inc | 3 |
| Scott’s Dual Arch Trays 100/bag Medium (White) | Scott’s Dental Supply L.L.C. | 1 |
Showing 12 of 31. All products under Tray, Fluoride, Disposable
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.