GL – 3 X 3 Sheets (28)
Catalogue number 260-033, listed by Great Lakes Dental Technologies, Ltd., United States, under Wax, Dental, Intraoral. 55 manufacturers in China are registered for this product code.
55manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (16), Guangdong (12), Hebei (6). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Yangzhou Yichuan Plastic Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 8 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| 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 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
Showing 12 of 55. All 55 manufacturers in China registered for Wax, Dental, Intraoral
Record
| Listed by | Great Lakes Dental Technologies, Ltd., United States |
|---|---|
| FDA product code | EGD |
| Device type | Wax, Dental, Intraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6890 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-05-18 |
| Record revised | 2021-02-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 260-033 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dental Casting | Aidite (Qinhuangdao) Technology Co., Ltd. | 103 |
| Rogson WAX, MDC Dental | MDC Dental | 82 |
| WAX Disk | Yamahachi Dental MFG. Co. | 69 |
| Wax, Dental, Intraoral | Gebdi Dental Products Gmbh | 61 |
| Paraffin WAX | Yamahachi Dental MFG. Co. | 48 |
| Wax, Dental, Intraoral | Yeti Dentalprodukte Gmbh | 46 |
| Henry Schein | Henry Schein, Inc. | 44 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 32 |
| Zcad TempFix | Henry Schein, Inc. | 23 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 19 |
| Zcad TempEsthetic | Henry Schein, Inc. | 17 |
| Aidite 3D Printing Model Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 17 |
Showing 12 of 151. All products under Wax, Dental, Intraoral
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.