Ardent
Ardent™ Articulating Paper Premium X Thin Blue .0025 Impregnated 140 Strips 63 microns
12manufacturers in China registered for this device type
6catalogue 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 | Whip-MIX Corp., United States |
|---|---|
| FDA product code | EFH |
| Device type | Paper, Articulation |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6140 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-27 |
| Record revised | 2025-11-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60206 | In distribution | |
| 60001 | In distribution | |
| 60013 | In distribution | |
| 60000 | In distribution | |
| 60007 | In distribution | |
| 60008 | 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 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Articulating Paper | Crosstex International | 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.