3m™
3M™ Custom Matrix.
7manufacturers in China registered for this device type
1catalogue number
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 | 3M Company, United States |
|---|---|
| FDA product code | KCQ |
| Device type | Tube Impression And Matrix |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6570 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-03 |
| Record revised | 2024-04-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2022-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXD-987 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| White Bite | White Bite, Inc. | 82 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 33 |
| E. Hahnenkratt GmbH | E. Hahnenkratt Gmbh | 23 |
| 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 |
| 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.