Darby Dental Supply, LLC
Articulating PPR Hrshoe RD/BL
12manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Anhui (3), Hebei (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Anhui JM Healthcare Products Co., Ltd. | Shouxian | Anhui | Manufacturer | 25 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Darby Dental Supply, LLC |
|---|---|
| FDA product code | EFH |
| Device type | Paper, Articulation |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6140 |
| Premarket notification | Exempt |
| Record published | 2024-09-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9501465 | 72 | In distribution | |
| 9501454 | 144 | In distribution | |
| 9501420 | 18 | In distribution | |
| 9501425 | 18 | In distribution | |
| 9503840 | In distribution | ||
| 9501455 | 144 | In distribution | |
| 9501460 | 144 | In distribution | |
| 9501467 | 144 | In distribution | |
| 9501505 | In distribution | ||
| 9501205 | 144 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AccuFilm® | Parkell, Inc. | 16 |
| Articulating paper/film | Whip-MIX Corp. | 13 |
| Bright Spot | Taub Products | 12 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Articulating Paper | Crosstex International | 6 |
| Ardent | Whip-MIX Corp. | 6 |
| TrollFoil | Directa AB | 6 |
| Benco | Benco Dental Supply Co. | 4 |
| Health-Tec/DHP Articulating Paper | Dental Health Products Inc | 4 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 4 |
| Flex Tab | Kerr Corporation | 4 |
| Health-Tec Temporary C&B Material 4:1 | Dental Health Products Inc | 4 |
Showing 12 of 64. All products under Paper, Articulation
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.