Henry Schein
Sectional Matrix Ring Refill
10manufacturers in China registered for this device type
9catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EKF |
| Device type | Instrument, Contouring, Matrix, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2019-05-29 |
| Record revised | 2024-02-05 (version 2) |
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 |
| Storage | Special storage condition: To be stored in dry and fresh place, protected from sunlight |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9007989 | 50 | In distribution | |
| 9007985 | 50 | In distribution | |
| 9007987 | 50 | In distribution | |
| 9007988 | In distribution | ||
| 9007987 | 50 | In distribution | |
| 9007985 | 50 | In distribution | |
| 9007984 | In distribution | ||
| 9007986 | 50 | In distribution | |
| 9007986 | 50 | 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 |
| Unimatrix | TDV Dental Ltda | 8 |
| Wagotrix | GoldenDent | 8 |
| Unimatrix R | TDV Dental Ltda | 7 |
| 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.