AccuFilm®
AccuFilm® II Booklet Red/Black (5 Booklets of 50)
12manufacturers in China registered for this device type
16catalogue 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 | Parkell, Inc., United States |
|---|---|
| FDA product code | EFH |
| Device type | Paper, Articulation |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-19 |
| Record revised | 2023-12-20 (version 7) |
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 |
| Storage | Storage environment temperature up to 50 °C; Special storage condition: Store product tightly sealed away from direct sunlight |
| Packaging | Box of 6, box of 5 |
| Distribution end date | 2021-09-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Black | 280 | In distribution | |
| S021-K | 280 | In distribution | |
| S020 | In distribution | ||
| Red | 280 | In distribution | |
| Black/Black | 280 | In distribution | |
| S015-K | 280 | In distribution | |
| S018-K | 280 | In distribution | |
| S020-K | In distribution | ||
| Red/Black | 280 | In distribution | |
| Red/Red | 280 | In distribution | |
| S054 | 100 | In distribution | |
| S017-K | 280 | In distribution | |
| Red/Black Booklet | 50 | In distribution | |
| Arch | 72 | Withdrawn | |
| Red/Black Booklet | 250 | Withdrawn | |
| Arch | 12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.