Surgical devices · 21 CFR 872 Subpart E
Surgical Bone File
FDA device type “File, Bone, Surgical”.
- Companies listing it
- 135109 makers
- Brands and models
- 173
- 510(k) clearances
- 40 in five years
- FDA name
- File, Bone, Surgical
510(k) clearances per year, 1976–2026
Companies that list EMI
135 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Premier Dental Products Company | United States | Maker | PREMIER BONE FILE | 28 | 2026 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Endo Files, Dental Engine Files, Endo Hand Files | 4 | 2022 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Integra LifeSciences Corporation | United States | Maker | Integra · MicroFrance · Miltex · Tactile Tone | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | File, Bone File, Interdental File | 2 | 2008 |
| GC Orthodontics | United States | Maker | DentaSonic | 2 | 2015 |
| Arnold Tuber Industries | United States | Maker | Bone file | 1 | 2009 |
| Osung Mnd Co Ltd | South Korea | Maker | BF1X · BF22 · BF45 | — | — |
| Zain's Medical Image | Pakistan | Maker | BONE FILE | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Dental Bone File Howard #12 · Dental Bone File Miller #21 · Dental Bone File Miller #52 · Dental Bone File Miller #64 · +1 | — | — |
| Metro Medical | Pakistan | Maker | Bone Files, Mille | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Hirschfeld File Scaler Mini n.3-7 · Hirschfeld File Scaler Mini n.5-11 · Miller bone file 1 · Miller bone file 2 · +5 | — | — |
| Signor Seven International | Pakistan | Maker | Bone Basin, Oval- Shape SKU 13-1200 · Bone Grinder Instrument SKU 13-1202 · #12 Howard Bone File SKU 11-814 · #12A Miller-Colburn Bone File SKU 11-709 · +7 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Bone files R1/R2 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Dental Studio | South Korea | Maker | MILLER 1X · MILLER 21 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Bone File | — | — |
| Commic Surgico | Pakistan | Maker | Bone File · Bone Rasp/File | — | — |
| ACH Medical Co., Ltd. | South Korea | Maker | Socket Bone File | — | — |
| Medcave Private Limited | Pakistan | Maker | Bone File | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT BONE FILES | — | — |
| Panorama International | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Accompany Surgical | Pakistan | Maker | Bone File | — | — |
| Lacigrus International | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | FILE BONE SURGICAL | — | — |
| Aesculap AG | Germany | Maker | BONE FILE | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | BONE FILE | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | Bone File | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | Bone File · FILE, BONE, SURGICAL | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Bone File · Miller Bone File | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Surgicrafts | Pakistan | Maker | EMI / FILE, BONE, SURGICAL | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | FILE | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Silver Plus Corp. | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | bone file,dental | — | — |
| Surgiscape | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EMI - FILE, BONE, SURGICAL | — | — |
| Choose Surgical Instruments | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Lohar Medical Company | Pakistan | Maker | EMI / FILE, BONE, SURGICAL | — | — |
| Medline Industries, LP | United States | Maker | Medline / Konig File, Bone, Surgical | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Bone Files | — | — |
| Daddy D Pro | Pakistan | Maker | Bone Files Dental | — | — |
| Mount Blonck Trading | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Teleflex | United States | Maker | KMEDIC · Pilling | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | FILE BONE | — | — |
| Surjex | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Mian Shahid Corp. | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| CDM Center of Excellence Ltd. | China | Maker | File, Bone, Surgical | — | — |
| Tecomet | United States | Maker | PFR | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| M.M Dental Corp | Pakistan | Maker | Bone file | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | FILE | — | — |
| Dr Frigz International Pvt Ltd | Pakistan | Maker | BONE FILE | — | — |
| Med2B Ltd. | Germany | Maker | FILE, BONE, SURGICAL | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | Bone Files | — | — |
| Sabokay Industries | Pakistan | Maker | File, Bone, Surgical | — | — |
| Darleys Surgical Co. | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Surgikare | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| T.A. Walthem & Company | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | Bone files / rasps | — | — |
| Nawaz and Sons | Pakistan | Maker | EMI / FILE, BONE, SURGICAL | — | — |
| Sabri Industries | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Zepf Medical Instrum | Germany | Maker | FILE | — | — |
| CM Instrumente GmbH | Germany | Maker | — | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | HOHMAN BONE LEVER. | — | — |
| NR Surgical Company | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Tim J. Prusaitis | United States | Maker | PRU-DENT | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | File, Bone, Surgical | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | File, Bone, Surgical | — | — |
| Power Dental USA | United States | Maker | File, Bone, Surgical | — | — |
| Ultra Surgical (Pvt.) Ltd. | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Meister Surgical Instruments | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| GSource LLC | United States | Maker | File, Bone, Surgical | — | — |
| Dufner Instrumente GmbH | Germany | Maker | FILE BONE, SURGICAL | — | — |
| Stomed Corp. | Pakistan | Maker | FILE, BONE, SURGICAL | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Niti engine file | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Pak Tools Surgical Instruments | Pakistan | Maker | BONE FILE | — | — |
| Zien Medical Technologies LLC | United States | Maker | File, Bone, Surgical | — | — |
| Hermann Mueller Medizintechnik GmbH | Germany | Maker | — | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| A. Handte Medizintechnik GmbH & Co. KG | Germany | Maker | — | — | — |
| addn solutions GmbH & Co. KG | Germany | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Berger Surgical Medical Products GmbH | Germany | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| Gulmag International | Pakistan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Oertel Medical GmbH | Germany | Maker | — | — | — |
| Rudolf Storz GmbH | Germany | Maker | — | — | — |
| Stork Instrumente GmbH | Germany | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | BONE FILE | 23 | 2025 |
| Biomet Microfixation | United States | Manufacturer | Bone File | 8 | 2021 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA #08, 21mm, Stainless Steel ISO Standard H-File · Valdent USA #10, 21mm, Stainless Steel ISO Standard H-File · Valdent USA #10, 31mm, Stainless Steel ISO Standard H-File · Valdent USA #15, 21mm, Stainless Steel ISO Standard H-File · +25 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Surgical File | — | — |
| STERIS Corporation | United States | Contract sterilizer | V. Mueller Bone File (ST-CFE) · V. Mueller Bone File Bayonet (WM-RR) | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | File | — | — |
| E A Beck & Company | United States | Repacker / relabeler | FILE, BONE, SURGICAL | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | Multiple | — | — |
| K&S Instruments | United States | Repacker / relabeler | Alden Surgical Bone File | — | — |
| Trinity Sterile Inc | United States | Manufacturer | Bone File | — | — |
| ambler surgical | United States | Repacker / relabeler | Ambler | — | — |
| Med Saver, Inc. | United States | Repacker / relabeler | MSI Precision Specialty Instruments | — | — |
| Boss Instruments Ltd | United States | Repacker / relabeler | — | — | — |
| Surgical Instrument | United States | Repacker / relabeler | FILE, BONE, SURGICAL | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Marina Medical Instruments | United States | Repacker / relabeler | Sharpener | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Boca Dental Regenerative, LLC. | United States | Lister | Boca Dental regenerative | — | — |
| Esse Dental Supply Inc. | United States | Lister | Bone Carrier | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 2 Mar 1992 | K914035 | MINI-MILL | Biomedical Composites, Ltd. |
| 16 Aug 1991 | K912989 | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | Wilde-USA, Inc. |
| 11 Jun 1985 | K851716 | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES | Artiberia |
| 9 Jan 1983 | K823676 | DISC NEEDLE SET #TX-8220 | Today'S Machining & Design, Inc. |
Official records: FDA product classification for EMI · 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