HySolate
HySolate SyntX Dam non-latex blue medium 5''x 5'' (127 x 127 mm), 30 pcs
23manufacturers in China registered for this device type
56catalogue 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 | DENT4YOU AG, Switzerland |
|---|---|
| FDA product code | EIE |
| Device type | Dam, Rubber |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-18 |
| Record revised | 2024-01-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 26 °C |
| Distribution end date | 2025-07-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60037566 | 30 | In distribution | |
| H00725 | In distribution | ||
| 60034434 | 52 | In distribution | |
| 60031354 | 36 | In distribution | |
| 60034424 | 52 | In distribution | |
| 60034437 | 52 | In distribution | |
| 60034435 | 52 | In distribution | |
| H09945 | 30 | In distribution | |
| 60034425 | 52 | In distribution | |
| H09105 | 15 | In distribution | |
| H09947 | 30 | In distribution | |
| 60037568 | 75 | In distribution | |
| H06522 | In distribution | ||
| H09946 | 30 | In distribution | |
| H00751 | In distribution | ||
| 60034428 | 36 | In distribution | |
| 60031352 | 36 | In distribution | |
| 60034429 | 36 | In distribution | |
| 60031351 | 36 | In distribution | |
| H09106 | 75 | In distribution | |
| 60034416 | 52 | In distribution | |
| 60034426 | 52 | In distribution | |
| 60034423 | 360 | In distribution | |
| 60034441 | 52 | In distribution | |
| H06524 | In distribution | ||
| 60034420 | 52 | In distribution | |
| 60034419 | 52 | In distribution | |
| 60034415 | 52 | In distribution | |
| 60037567 | 30 | In distribution | |
| H09928 | 15 | In distribution | |
| 60034417 | 52 | In distribution | |
| 60034431 | 360 | In distribution | |
| 60034443 | 36 | In distribution | |
| H02779 | 5 | In distribution | |
| 60034436 | 36 | In distribution | |
| 60034418 | 52 | In distribution | |
| H08040 | In distribution | ||
| 60034414 | 52 | In distribution | |
| 60034421 | 52 | In distribution | |
| 60034442 | 36 | In distribution | |
| H00750 | 20 | In distribution | |
| 60034440 | 360 | In distribution | |
| 60034439 | 364 | In distribution | |
| 60033845 | 2 | In distribution | |
| 60034422 | 364 | In distribution | |
| H06523 | In distribution | ||
| 60034432 | 364 | In distribution | |
| 60034430 | 36 | In distribution | |
| 60034427 | 36 | In distribution | |
| 60034433 | 36 | In distribution | |
| 60031353 | 36 | In distribution | |
| H09950 | In distribution | ||
| H06525 | In distribution | ||
| 60034438 | 36 | In distribution | |
| 60031355 | 360 | In distribution | |
| 60033844 | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 83 |
| 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 |
| 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.