Hygenic
Convenience Dam Pack Medium 5x5 Pastels
23manufacturers in China registered for this device type
83catalogue numbers in this listing
1recall
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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EIE |
| Device type | Dam, Rubber |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2024-11-08 (version 2) |
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 |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight; Storage environment temperature 32 to 80 °F |
| Distribution end date | 2025-07-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H09946 | 30 | In distribution | |
| H02148C | In distribution | ||
| H04640 | 52 | In distribution | |
| H02900C | In distribution | ||
| H00533 | 36 | In distribution | |
| H02149C | In distribution | ||
| H00540 | 36 | In distribution | |
| H00504 | In distribution | ||
| H00539 | 36 | In distribution | |
| H00535 | 36 | In distribution | |
| H02141 | 52 | In distribution | |
| H09945C | In distribution | ||
| H00524 | 52 | In distribution | |
| H04644 | 36 | In distribution | |
| H04643 | 52 | In distribution | |
| H02144 | 52 | In distribution | |
| H02147C | In distribution | ||
| H00541 | 36 | In distribution | |
| H00525 | 52 | In distribution | |
| H02143 | 52 | In distribution | |
| H03530 | 36 | In distribution | |
| H03530C | In distribution | ||
| H02146 | 36 | In distribution | |
| H01442 | In distribution | ||
| H07315 | 36 | In distribution | |
| H00534C | In distribution | ||
| H02148 | 36 | In distribution | |
| H00750C | In distribution | ||
| H04639 | 36 | In distribution | |
| H02778C | In distribution | ||
| H04241 | 364 | In distribution | |
| H00538 | 36 | In distribution | |
| H11678 | 36 | In distribution | |
| H04245 | 360 | In distribution | |
| H00523 | 52 | In distribution | |
| H04237 | 364 | In distribution | |
| H11625C | In distribution | ||
| H01440 | In distribution | ||
| H07317 | 360 | In distribution | |
| H11625 | 36 | In distribution | |
| H02142 | 52 | In distribution | |
| H04243 | 360 | In distribution | |
| H04247 | 360 | In distribution | |
| H01443 | In distribution | ||
| H00534 | 36 | In distribution | |
| H00539C | In distribution | ||
| H04642 | 36 | In distribution | |
| H11624C | In distribution | ||
| H01441 | In distribution | ||
| H04641 | 52 | In distribution | |
| H04240 | 364 | Withdrawn | |
| H11690 | 3 | Withdrawn | |
| H02147 | 36 | Withdrawn | |
| H04246 | 360 | Withdrawn | |
| H02174 | Withdrawn | ||
| H00503 | Withdrawn | ||
| H09106 | 75 | Withdrawn | |
| H00531 | 52 | Withdrawn | |
| H09928 | 15 | Withdrawn | |
| H00519 | Withdrawn | ||
| H00750 | 52 | Withdrawn | |
| H11677 | 52 | Withdrawn | |
| H04236 | 364 | Withdrawn | |
| H11675 | 52 | Withdrawn | |
| H00529 | 52 | Withdrawn | |
| H00530 | 52 | Withdrawn | |
| H04242 | 360 | Withdrawn | |
| H11676 | 36 | Withdrawn | |
| H00536 | 36 | Withdrawn | |
| H07316 | 7 | Withdrawn | |
| H02175 | Withdrawn | ||
| H09945 | 30 | Withdrawn | |
| H11624 | 52 | Withdrawn | |
| H00526 | 52 | Withdrawn | |
| H00514 | Withdrawn | ||
| H04239 | 364 | Withdrawn | |
| H09105 | 15 | Withdrawn | |
| H11627 | 36 | Withdrawn | |
| H11626 | 51 | Withdrawn | |
| H02149 | 36 | Withdrawn | |
| H03529 | 52 | Withdrawn | |
| H02177 | Withdrawn | ||
| H07314 | 52 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Cranberry | Ascend Eagle, Inc. | 13 |
Showing 12 of 105. All products under Dam, Rubber
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-12-11 | Class II | Packaging change control | Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. | 32 boxes, 15 individual dams per box | 2016-08-26 |
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.