Medicom Denticare PRO-Tray
Medicom Denticare Disposable Fuoride GEL Tray
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 | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | KMT |
| Device type | Tray, Fluoride, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6870 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-01-15 |
| Record revised | 2021-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Special storage condition: Cool dry place |
| Packaging | Outer case of 15, outer case of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10029-M | 50 | In distribution | |
| 10030-M | 100 | In distribution | |
| 10030-S | 100 | In distribution | |
| 10029-L | 50 | In distribution | |
| 10029-S | 10 | In distribution | |
| 10030-L | 100 | 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 |
| Premium Plus | Premium Plus (Dongguan) Limited | 6 |
| Young | Young Dental Manufacturing I, LLC | 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.