Integra® Miltex®
Composite, 12, GTX, Double-Ended, Black-Green, Tactile Tone™
10manufacturers in China registered for this device type
48catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKF |
| Device type | Instrument, Contouring, Matrix, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2022-07-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80-6009 | Withdrawn | |
| TD15X | Withdrawn | |
| 80-6007 | Withdrawn | |
| TD8X | Withdrawn | |
| 70-202 | Withdrawn | |
| TD4X | Withdrawn | |
| 70-212 | Withdrawn | |
| TD14X | Withdrawn | |
| 70-213 | Withdrawn | |
| TD6X-RY | Withdrawn | |
| 70-201 | Withdrawn | |
| TD9X | Withdrawn | |
| 80-6025 | Withdrawn | |
| 80-6002 | Withdrawn | |
| TDFR3X | Withdrawn | |
| TD9X-GW | Withdrawn | |
| TDK3 | Withdrawn | |
| TD12X-KG | Withdrawn | |
| 80-6004 | Withdrawn | |
| 80-6003 | Withdrawn | |
| 80-6006 | Withdrawn | |
| 80-6031 | Withdrawn | |
| 70-206 | Withdrawn | |
| TD2X-RY | Withdrawn | |
| TD3X | Withdrawn | |
| TDS2X | Withdrawn | |
| 70-204 | Withdrawn | |
| 80-6040 | Withdrawn | |
| TD6XLL | Withdrawn | |
| TDDX | Withdrawn | |
| TD2X | Withdrawn | |
| TD11X | Withdrawn | |
| 70-203 | Withdrawn | |
| 80-6005 | Withdrawn | |
| 80-6012 | Withdrawn | |
| 70-211 | Withdrawn | |
| TD4XPP | Withdrawn | |
| TD4X-KG | Withdrawn | |
| TD7X | Withdrawn | |
| TDFR2X | Withdrawn | |
| TD12X-RY | Withdrawn | |
| TD5X | Withdrawn | |
| TD12X | Withdrawn | |
| TDK4 | Withdrawn | |
| TD6X | Withdrawn | |
| 70-205 | Withdrawn | |
| TD4X-KK | Withdrawn | |
| 70-214 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.