Surgical devices · 21 CFR 872 Subpart E
Operative Matrix Contouring Instrument
FDA device type “Instrument, Contouring, Matrix, Operative”.
- Companies listing it
- 3627 makers
- Brands and models
- 291
- 510(k) clearances
- 00 in five years
- FDA name
- Instrument, Contouring, Matrix, Operative
Companies that list EKF
36 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Matrix Ring, Matrix Bands, Sectional Matrix system, Metal Matrix Strips · Reel Matrix System, Reel Matrices, Saddle Contoured Metal Matrices Universal Kit for Premolars, · Sectional Contoured Metal Matrices, Rectangular Matrix Bands,Coat matrix bands, | 1 | 2025 |
| Integra LifeSciences Corporation | United States | Maker | Miltex · Tactile Tone | 2 | 2014 |
| Hager Worldwide, Inc. | United States | Maker | Almore Microfil Composite Instruments · Madam Butterfly · Mylar · Occlu-Spot · +1 | 2 | 2005 |
| TOR VM Ltd. | Russia | Maker | Cat.#1.134 Plastic-Metal Combined Matrix Bands for Molars · Cat.#1.141 Transparent Cervical Matrix Bands · Cat.#1.190 Transparent Contoured Matrices for Premolars · Cat.#1.191 Transparent Contoured Matrices for Molars · +178 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Composite Spatula n.11 · Composite Spatula n.6 · Composite Spatula No. 11 BLK · Mini Flexible Spatula For Resin n. 1 · +23 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Tofflemire Matrix Bands | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Coat matrix bands,Reel Matrix System, Reel Matrices, · Matrix Bands, Sectional Matrix system, Metal Matrix Strips, matrices · Saddle Contoured Metal Matrices Universal Kit for Premolars,Matrix Ring, · Sectional Contoured Metal Matrices, Rectangular Matrix Bands | — | — |
| TDV Dental Ltda | Brazil | Maker | CERVICAL MATRIX · DECIDUOUS MATRICES · IsoTape · METALLIC MATRIX STRIP · +26 | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Dental Sectional Contoured Matrices Kits, Matrix Bands | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE | — | — |
| Panorama International | Pakistan | Maker | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE | — | — |
| Aesculap AG | Germany | Maker | aesculap | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Tofflemire matrix bands | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | CONTOURING · MATRIX | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Matrices Refill Sectional contoured metal | — | — |
| Dentech Corp. | Japan | Maker | Dentech Corporation | — | — |
| Sabokay Industries | Pakistan | Maker | Matrix, Dental | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Matrices Refill Sectional contoured metal | — | — |
| Palmero Healthcare | United States | Maker | Matrix Strips | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| Greater Curve | United States | Maker | Greater Curve Large Brass Sectional Matrix · Greater Curve Micro Thin matrix bands · Greater Curve Micro U-Band matrix bands · Greater Curve Micro Wide matrix bands · +7 | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Operative Contouring Matrix Instrument | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Aesculap, Inc. | United States | Lister | aesculap | 2 | 2006 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | matrix band | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| SPS/Crosstex International | United States | Manufacturer | Matrix Strips | — | — |
| GoldenDent | United States | Repacker / relabeler | Wagotrix · Wagotrix Sectional Matrix System | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Tofflemire Matrix Bands | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Matrix Contouring Instrument | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
Official records: FDA product classification for EKF · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026