Compspan™ Composite Luting Cement
Compspan™ Composite Luting Cement Complete Package
41manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EBH |
| Device type | Material, Impression Tray, Resin |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3670 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Refrigeration extends shelf life. Shelf life is 12 months when stored at 75° F (24° C) or below. |
| Sizes | Weight 5 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 655100 | Weight 5 g | In distribution |
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 |
| COE Tray Plastic™ | GC America Inc. | 28 |
| 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 |
Showing 12 of 197. All products under Material, Impression Tray, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K923979 | 1992-11-17 |
| K872210 | 1987-06-22 |
| K854042 | 1985-11-07 |
| K844471 | 1985-02-08 |
| K813550 | 1982-02-24 |
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.