COE Tray Plastic™
COE TRAY PLASTIC™ Professional Package, Regular Set White, powder 1 lb (454g), liquid 6 oz. (177mL), Coe-sep 2 oz. (59mL)
41manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Guangdong (8), Shanghai (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
Showing 12 of 41. All 41 manufacturers in China registered for Material, Impression Tray, Resin
Record
| Listed by | GC America Inc., United States |
|---|---|
| FDA product code | EBH |
| Device type | Material, Impression Tray, Resin |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3670 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-07-07 |
| Record revised | 2020-02-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 70 to 77 °F; Storage environment temperature 21 to 25 °C |
| Sizes | Total volume 117 to 3784 ml; weight 1 to 25 lb; total volume 6 Fluid Ounce |
| Distribution end date | 2020-02-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 240092 | Total Volume 473 ml | In distribution |
| 240111 | In distribution | |
| 240191 | Total Volume 117 ml | In distribution |
| 240012 | Weight 1 lb | In distribution |
| 240013 | In distribution | |
| 240093 | Total Volume 946 ml | In distribution |
| 240091 | Total Volume 6 Fluid Ounce | In distribution |
| 240013 | In distribution | |
| 240192 | Total Volume 473 ml | In distribution |
| 240016 | Weight 25 lb | In distribution |
| 240011 | In distribution | |
| 240014 | Weight 3 lb | In distribution |
| 240016 | Weight 25 lb | In distribution |
| 240113 | In distribution | |
| 240093 | Total Volume 946 ml | In distribution |
| 240012 | Weight 1 lb | In distribution |
| 240111 | In distribution | |
| 240192 | Total Volume 473 ml | In distribution |
| 240113 | In distribution | |
| 240191 | Total Volume 117 ml | In distribution |
| 240091 | Total Volume 6 Fluid Ounce | In distribution |
| 240011 | In distribution | |
| 240193 | Total Volume 946 ml | In distribution |
| 240014 | Weight 3 lb | In distribution |
| 240092 | Total Volume 473 ml | In distribution |
| 240193 | Total Volume 946 ml | In distribution |
| 240194 | Total Volume 3784 ml | Withdrawn |
| 240094 | Total Volume 3784 ml | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| COE® | GC America Inc. | 400 |
| Power Dental USA | Power Dental U.S.A. Inc. | 56 |
| Plasdent | Plasdent Corp. | 41 |
| JMU | JMU Dental, Inc | 40 |
| Vertex-Dental BV | Vertex-Dental B.V. | 34 |
| Ou Nuo | Changzhou OU NUO Medical Equipment Co., Ltd. | 28 |
| Excellent | Plasdent Corp. | 22 |
| Shining 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 17 |
| Smart Dent ® | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 17 |
| Britedent | Bright Supply Inc | 16 |
| iSmile | Ismile Dental Products Inc. | 15 |
| Excellent-Colors | Plasdent Corp. | 13 |
Showing 12 of 197. All products under Material, Impression Tray, Resin
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.