Insti-Dam®
Insti-Dam Relaxed Fit 5pk for Isolation Power Pack
23manufacturers in China registered for this device type
3catalogue 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 | Zirc Dental Products, Inc., United States |
|---|---|
| FDA product code | EIE |
| Device type | Dam, Rubber |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-07 |
| Record revised | 2026-02-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 121 mm; width 124 mm; height 70 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 50Z457-360 | Length 121 mm | 5 | In distribution |
| 50Z459-360 | Length 121 mm | 5 | In distribution |
| 50Z457 | Length 121 mm | 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 |
| 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.