Unimatrix R
Unimatrix R - 100 Matrices + 2 Rings + 8 Triangular Silicone Tips (PT/ES/EN/FR/DE/IT/NL/CZ)
10manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Hebei (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| 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 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
Record
| Listed by | TDV Dental Ltda, Brazil |
|---|---|
| FDA product code | EKF |
| Device type | Instrument, Contouring, Matrix, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-28 |
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, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0003020102 | In distribution | |
| 0003020103 | In distribution | |
| 0003020087 | In distribution | |
| 0003020086 | In distribution | |
| 0003020085 | In distribution | |
| 0003020081 | In distribution | |
| 0003020104 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 48 |
| Quinelato | Schobell Industrial Ltda | 19 |
| Health-Tec/DHP Matrix Bands | Dental Health Products Inc | 18 |
| GoldenDent | GoldenDent | 13 |
| Dentech | Dentech Corp. | 12 |
| Metallic Matrix Strip | TDV Dental Ltda | 9 |
| Henry Schein | Henry Schein, Inc. | 9 |
| Unimatrix | TDV Dental Ltda | 8 |
| Wagotrix | GoldenDent | 8 |
| Cervical Matrix | TDV Dental Ltda | 7 |
| Aesculap | Aesculap AG | 6 |
| Schobell | Schobell Industrial Ltda | 5 |
Showing 12 of 58. All products under Instrument, Contouring, Matrix, Operative
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.