E. Hahnenkratt GmbH
12-Pack: Tofflemire No. 113
7manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Shaoguan Guanghua Plastic AND Hardwear Products Ltd | Shaoguan | Guangdong | Manufacturer | 2 |
Record
| Listed by | E. Hahnenkratt Gmbh, Germany |
|---|---|
| FDA product code | KCQ |
| Device type | Tube Impression And Matrix |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6570 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-05 |
| Record revised | 2024-12-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40X6 | 12 | In distribution | |
| 40X5 | 12 | In distribution | |
| 40X113 | 12 | In distribution | |
| 40X4 | 12 | In distribution | |
| 41X3 | 100 | In distribution | |
| 40X150 | 12 | In distribution | |
| 40X3 | 12 | In distribution | |
| 40X11 | 12 | In distribution | |
| 40X14 | 12 | In distribution | |
| 41X2 | 100 | In distribution | |
| 40X151 | 12 | In distribution | |
| 40X150 | 12 | In distribution | |
| 40X102 | 12 | In distribution | |
| 40×16 | 12 | In distribution | |
| 40X1 | 12 | In distribution | |
| 40X2 | 12 | In distribution | |
| 41X1 | 100 | In distribution | |
| 40X7 | 12 | In distribution | |
| 40X12 | 12 | In distribution | |
| 41X4 | 100 | In distribution | |
| 40X103 | 12 | In distribution | |
| 40X13 | 12 | In distribution | |
| 40X101 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| White Bite | White Bite, Inc. | 82 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 33 |
| Gripper™ Soft Copper Band | Parkell, Inc. | 21 |
| 3D Dental | 3D Dental Designs AND Development, LLC | 17 |
| 3M™ Espe™ | 3M Company | 17 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 7 |
| JMU | JMU Dental, Inc | 4 |
| 3M™ | 3M Company | 1 |
| Solventum US LLC | Solventum US LLC | 1 |
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.