Surgical devices · 21 CFR 872 Subpart E
Operative Margin Finishing File
FDA device type “File, Margin Finishing, Operative”.
- Companies listing it
- 1715 makers
- Brands and models
- 30
- 510(k) clearances
- 20 in five years
- FDA name
- File, Margin Finishing, Operative
510(k) clearances per year, 1976–2026
Companies that list EKA
17 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | SmartStrip | 203 | 2026 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC · MARGIN FILE · MULIPLE | 8 | 2012 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | Trident Dental - Interproximal Saw Blade and Abrasive | 2 | 1986 |
| B&L Biotech Co., Ltd. | South Korea | Maker | BLPOT-BPFB · BLPOT-BPFG · BLPOT-BPFP · BLPOT-BPFS3 · +1 | 1 | 2006 |
| Osung Mnd Co Ltd | South Korea | Maker | FSH3-7 · FSH5-11 · PDS1-2S · PDS3-4S · +1 | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | File, Margin Finishing, Operative | — | — |
| Medcave Private Limited | Pakistan | Maker | File | — | — |
| Panorama International | Pakistan | Maker | FILE, MARGIN FINISHING, OPERATIVE | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Surgicrafts | Pakistan | Maker | EKA / FILE, MARGIN FINISHING, OPERATIVE | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · MicroDent | — | — |
| 麦迪卡有限公司 MedicNRG Ltd | Israel | Maker | Gentlefile · Gentlefile Brush · Gentlefile Endo File | — | — |
| Unip Berhad | Malaysia | Maker | STRIP | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Margin Trimmer | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 26 Jul 1983 | K830764 | FR ROOT CANAL SEALER | Shizai Corp. |
| 3 Nov 1982 | K822464 | OBTURATION GUTTA | U.S. Shizai Corp. |
Official records: FDA product classification for EKA · 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