Ultradent
DermaDam Latex Sample - 2pk (1 Medium / 1 Heavy)
23manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangxi (4), Jiangsu (3). 2 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 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Guangdong Xinuo Personal Care Products Co., Ltd. | Yunfu | Guangdong | Manufacturer | 33 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
Showing 12 of 23. All 23 manufacturers in China registered for Dam, Rubber
Record
| Listed by | Four D Rubber Co Ltd, United Kingdom |
|---|---|
| FDA product code | EIE |
| Device type | Dam, Rubber |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Medium | 90 | In distribution | |
| Medium | 2 | In distribution | |
| Medium | 60 | In distribution | |
| Medium | 2 | In distribution | |
| Heavy | 36 | In distribution | |
| Medium | 52 | In distribution | |
| Medium | 2 | In distribution | |
| Heavy | 2 | In distribution | |
| Heavy | 36 | In distribution | |
| Heavy | 52 | In distribution | |
| Medium | 30 | In distribution | |
| Medium | 2 | In distribution | |
| Medium | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 83 |
| HySolate | DENT4YOU AG | 56 |
| Pomee | Pomee Corporation | 54 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 28 |
| Biodam | Four D Rubber Co Ltd | 21 |
| Dental Dams | Crosstex International | 20 |
| Isodam | Four D Rubber Co Ltd | 19 |
| Benco | Benco Dental Supply Co. | 17 |
| Hedy Dental DAM | AMD Medicom Inc. | 16 |
| Medicom Safetouch | AMD Medicom Inc. | 14 |
| C-Root | Beijing C-Root Dental Medical Devices Co., Ltd. | 14 |
| Cranberry | Ascend Eagle, Inc. | 13 |
Showing 12 of 105. All products under Dam, Rubber
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.