Surgical devices · 21 CFR 872 Subpart E
Operative Cutting Instrument
FDA device type “Instrument, Cutting, Operative”.
- Companies listing it
- 6453 makers
- Brands and models
- 96
- 510(k) clearances
- 20 in five years
- FDA name
- Instrument, Cutting, Operative
510(k) clearances per year, 1976–2026
Companies that list EKD
64 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Gauge for Gutta-Percha-Points · R1, R1 Plus | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| Premier Dental Products Company | United States | Maker | Black Cutting Hatchet · Black Cutting Instrument · Calif Cutting Instrument | 28 | 2026 |
| Jeil Medical Corporation | South Korea | Maker | CUTTING INSTRUMENT | 9 | 2026 |
| Biomaterials Korea, Inc. | South Korea | Maker | B0-3055 · B0-5050 · MS saw(Left)-A · MS saw(Right)-A · +30 | 5 | 2023 |
| Leone S.P.A. | Italy | Maker | Surgical instruments | 4 | 2025 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | Endodontic Obturation Devices | 2 | 2022 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Storz AM Mark GmbH | Germany | Maker | Cutting Instrument | 2 | 2008 |
| Osung Mnd Co Ltd | South Korea | Maker | TNC100 · TNC165 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Discoide Cleoide Carver · Hollenback Carver n. 3 · Hollenback Carver n. 3S · Hollenback Carver n. 3SS | — | — |
| 株式会社ＹＤＭ | Japan | Maker | Wire Cutter YS-601 · Wire Cutter YS-602 KI · Wire Cutter YS-603 Standard | — | — |
| TDV Dental Ltda | Brazil | Maker | MICROCUT · MICROCUT MANUAL | — | — |
| Technimen Skillers | Pakistan | Maker | AL · FRAME SAW WITH SPRING HANDLE SURGIC | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Cutting Instrument | — | — |
| Nordent MFG., Inc. | United States | Maker | CHISELS · HATCHETS · HOES · NORDENT MARGIN TRIMMERS | — | — |
| Panorama International | Pakistan | Maker | INSTRUMENT, CUTTING, OPERATIVE | — | — |
| Accompany Surgical | Pakistan | Maker | CUTTER | — | — |
| Lacigrus International | Pakistan | Maker | INSTRUMENT, CUTTING, OPERATIVE | — | — |
| Aesculap AG | Germany | Maker | CUTTING INSTRUMENT | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | CUTTING INSTRUMENTS | — | — |
| Denta Craft Instruments | Pakistan | Maker | CUTTER | — | — |
| Medisporex Private Limited | Pakistan | Maker | Margin Trimmer | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | CUTTING OPERATIVE INSTRUMENT | — | — |
| Mident Ltd | United Kingdom | Maker | Dental Cutting Chisel | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | DOWN PACK | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Dental Hand Instruments | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | MARGIN TRIMMER | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Med2B Ltd. | Germany | Maker | INSTRUMENT, CUTTING, OPERATIVE | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | — | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | SURGICAL BURS · VARIOUS TYPES OF BONE CUTTERS | — | — |
| Hospimed Mfg | Pakistan | Maker | Instrument Cutting Operative | — | — |
| Weldon Instruments | Pakistan | Maker | INSTRUMENT, CUTTING, OPERATIVE | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| ACURATA GMBH & CO. KGaA | Germany | Maker | Acurata | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| A. BETZLER GmbH & Co. KG | Germany | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Eltek Instruments (Pvt.) Ltd. | Pakistan | Maker | — | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| KAPP Surgical GmbH | Germany | Maker | — | — | — |
| Motion Dental Equipment Corp. | Taiwan | Maker | — | — | — |
| Rmo, Inc. | United States | Manufacturer | Schweickhardt/Apex cutter | 1 | 1990 |
| Sotera Health LLC | United States | Contract manufacturer | Propel Device PT contra angle | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| Practicon, Inc. | United States | Manufacturer | GP Cut Gutta Percha Cutter · GP Cut Replacement Tips | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| ambler surgical | United States | Repacker / relabeler | Ambler | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Contract manufacturer | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 2 Jul 1985 | K851723 | 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS | Artiberia |
| 6 Jul 1982 | K821790 | BEACH EXCAVATOR'S NO. 1 & NO. 2 | Pacific Dental Corp. |
Official records: FDA product classification for EKD · 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