SoundSeal
Power bleaching: SoundSeal is used to protect the gingival during power bleaching procedures. Block-out resin: SoundSeal is used to block out undercuts and gingival embrasures prior to…
Power bleaching: SoundSeal is used to protect the gingival during power bleaching procedures. Block-out resin: SoundSeal is used to block out undercuts and gingival embrasures prior to taking impressions for crowns and bridges. Sandblasting: SoundSeal is used to mask and protect the gingiva during sandblasting. It is also placed on the areas of teeth to be masked during the sandblasting process.
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 | Sonendo, Inc., United States |
|---|---|
| FDA product code | EIE |
| Device type | Dam, Rubber |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K022522 |
| Record published | 2018-01-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FG-008-00002 | 10 | 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 |
| Ultradent | Four D Rubber Co Ltd | 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.