Articulating Paper/film
A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device. Ardent™…
A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device. Ardent™ Horseshoe / Full Arch Articulating Paper Blue/Blue.0025
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 | 2020-08-17 |
| Record revised | 2025-11-06 (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 |
| Distribution end date | 2025-11-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60101 | In distribution | |
| 60202 | In distribution | |
| 60100 | In distribution | |
| 60201 | In distribution | |
| 60005 | In distribution | |
| 60004 | In distribution | |
| 60006 | In distribution | |
| 60200 | In distribution | |
| 60003 | Withdrawn | |
| 60204 | Withdrawn | |
| 60205 | Withdrawn | |
| 60203 | Withdrawn | |
| 60002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AccuFilm® | Parkell, Inc. | 16 |
| 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 |
| 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.