Surgical devices · 21 CFR 872 Subpart E
Surgical Bone Chisel
FDA device type “Chisel, Bone, Surgical”.
- Companies listing it
- 146120 makers
- Brands and models
- 244
- 510(k) clearances
- 20 in five years
- FDA name
- Chisel, Bone, Surgical
510(k) clearances per year, 1976–2026
Companies that list EML
146 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Chisel | 212 | 2026 |
| Ossvis Co., Ltd. | South Korea | Maker | OV Chisel | 7 | 2024 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Premier Dental Products Company | United States | Maker | Premier | 28 | 2026 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Bone Chisel · Bone Splitting Chisel · Osteotome V | 1 | 2026 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co., LLC | 8 | 2012 |
| SYNTHES (USA) Products LLC | United States | Maker | chisel | 7 | 2020 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | chisel | 5 | 2013 |
| Storz AM Mark GmbH | Germany | Maker | Chisel · Gauge | 2 | 2008 |
| Arnold Tuber Industries | United States | Maker | Bone Chisel | 1 | 2009 |
| Osung Mnd Co Ltd | South Korea | Maker | CHBC1 · CHC13K-TG · CHC36-37 · CHCO1 · +5 | — | — |
| Zain's Medical Image | Pakistan | Maker | BONE CHISEL | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Alexander chisel 4mm/n. 1 · Alexander chisel 4mm/n. 2 · Alexander gouge 4mm/n. 3 · Bendable periotome, angled · +55 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Bone chisels 1/2/3/4 · Bone chisels R1/R2/R3/R4/R5/R6 · Bone spilting Chisel KGPZ15/ KGPZ20/ KGPZ25/ KGPZ3 · Chisel 1#/2#/3#/4#/5#/6# · +3 | — | — |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | xp-BS1-V · xp-BS1-V 2 · xp-BS2L-V · xp-BS2L-V 2 · +34 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Technimen Skillers | Pakistan | Maker | Sheehan Chisels, Gardner Chisel, Coupland Chisel, Elevator Chisel, Freer Chisel, Hibbs, Chisel, Alexander Chisel · Wakefield Chisel, Periosteal Chisel, Buckley Bone Chisel | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Bone Chisel | — | — |
| Pomee Corporation | Pakistan | Maker | Bone Chisels | — | — |
| Medcave Private Limited | Pakistan | Maker | Chisel | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT BONE CHISELS | — | — |
| Panorama International | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Accompany Surgical | Pakistan | Maker | Bone Chisel | — | — |
| Lacigrus International | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | CHISEL BONE SURGICAL | — | — |
| Aesculap AG | Germany | Maker | BONE CHISEL | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | CHISELS | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | Bone Chisel | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | CHISEL, BONE, SURGICAL · HILBRO INSTRUMENTS | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Surgicrafts | Pakistan | Maker | EML / CHISEL, BONE, SURGICAL | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | BONE CHISELS | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Bone Chisel | — | — |
| Harf Industries | Pakistan | Maker | Bone packer · CHISEL, BONE, SURGICAL · Friedman Bone Rongeur,Boehler Rongeur 6", (15cm) | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | BONE CHISEL | — | — |
| Surgiscape | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Maryam Trading | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EML - CHISEL, BONE, SURGICAL | — | — |
| Choose Surgical Instruments | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Lohar Medical Company | Pakistan | Maker | EML / CHISEL, BONE, SURGICAL | — | — |
| Acme Commercial Ways Ltd. | Pakistan | Maker | Bone Chisel | — | — |
| Medline Industries, LP | United States | Maker | Medline / Konig Chisel, Bone, Surgical | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Surgical Bone Chisel | — | — |
| Mount Blonck Trading | Pakistan | Maker | FORK, TUNING | — | — |
| Teleflex | United States | Maker | MULTIPLE SURGICAL BONE CHISELS · PILLING | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | CHISEL BONE | — | — |
| Surjex | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| Jabil Inc. | United States | Maker | chisel | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Mian Shahid Corp. | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Tecomet | United States | Maker | Narrow Cement Removal Gouge, Long · TURON, KEELED GLENOID, DRILL GUIDE 2 | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| G.S.T. Corporation Limited | India | Maker | GSTC · Heuer | — | — |
| Med2B Ltd. | Germany | Maker | CHISEL, BONE, SURGICAL | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Armatech International | Pakistan | Maker | Bone Chisels | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | CHISEL, BONE, SURGICAL, STILL BONE CHISELS | — | — |
| Sabokay Industries | Pakistan | Maker | Chisel, Bone, Surgical | — | — |
| Darleys Surgical Co. | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Hazel Enterprises | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Surgikare | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| T.A. Walthem & Company | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Washington Surgical International | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Madina Surgical Works | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Nawaz and Sons | Pakistan | Maker | EML / CHISEL, BONE, SURGICAL | — | — |
| Sabri Industries | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Zepf Medical Instrum | Germany | Maker | — | — | — |
| Concise Enterprises | Pakistan | Maker | — | — | — |
| NR Surgical Company | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Asanus Medizintechnik GmbH | Germany | Maker | ASANUS | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Chisel, Bone, Surgical | — | — |
| Power Dental USA | United States | Maker | CHISEL, BONE, SURGICAL | — | — |
| Fetzer Medical GmbH & Co.KG | Germany | Maker | Bone Chisel | — | — |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | Maker | Femoral Box Chisel (80300040) | — | — |
| Meister Surgical Instruments | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| GSource LLC | United States | Maker | Chisel, Bone, Surgical | — | — |
| Weldon Instruments | Pakistan | Maker | EML / CHISEL, BONE, SURGICAL | — | — |
| Dufner Instrumente GmbH | Germany | Maker | BONE CHISELS | — | — |
| M.J. Instruments Company (Pvt.) Ltd. | Pakistan | Maker | AMPUTATING & RESECTION SAWS / BONE SURGERY · HAND DRILLS / BONE SURGERY · LEAD HANDS / BONE SURGERY · SCREW DRIVERS / BONE SURGERY | — | — |
| Stomed Corp. | Pakistan | Maker | CHISEL, BONE, SURGICAL | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| NN Inc Power Solutions | United States | Maker | CHISEL, BONE, SURGICAL | — | — |
| Encore Medical LP | United States | Maker | ENCORE CHISEL · FEMORAL CUTTING CHISEL | — | — |
| Instrumental Machine & Development | United States | Maker | N/A | — | — |
| Lenox-Maclaren Surgical Corp. | United States | Maker | LENOX MACLAREN | — | — |
| NG Instruments, Inc dba Avalign Cutting Instruments | United States | Maker | Bone Remover · Inbone - Wright Medical | — | — |
| SUBAN Instruments Germany GmbH | Germany | Maker | — | — | — |
| MicroPort Orthopedics Inc. | United States | Maker | Chisel | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Turnco Tool & Instrument, Inc. | United States | Maker | Empowr Box Cut Guide Chisel | — | — |
| Ulrich AG | Switzerland | Maker | Ulrich Swiss | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| A. Handte Medizintechnik GmbH & Co. KG | Germany | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| Eisenhut Instrumente GmbH | Germany | Maker | — | — | — |
| Fetzer Surgical, LLC | United States | Maker | — | — | — |
| Geister Medizintechn | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| HGR Instrumente GmbH | Germany | Maker | — | — | — |
| Innomed Inc. | United States | Maker | — | — | — |
| Karl Klappenecker GmbH & Co. KG | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| PRO-MED Instrumente GmbH | Germany | Maker | — | — | — |
| Rudolf Storz GmbH | Germany | Maker | — | — | — |
| Stengelin Medical | Germany | Maker | — | — | — |
| Bicon, LLC | United States | Manufacturer | Chisel | 18 | 2015 |
| Biomet Microfixation | United States | Manufacturer | Chisel · Osteotome | 8 | 2021 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · MicroFrance · Miltex | 2 | 2014 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| PDT Inc. | United States | Contract manufacturer | Bone scraper | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Chisel | — | — |
| E A Beck & Company | United States | Repacker / relabeler | CHISEL, BONE, SURGICAL | — | — |
| K&S Instruments | United States | Repacker / relabeler | Alden Surgical Chisel | — | — |
| 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 | bone chisel | — | — |
| George Tiemann & Co. | United States | Repacker / relabeler | HIBBS | — | — |
| Surgical Instrument | United States | Repacker / relabeler | CHISEL, BONE, SURGICAL | — | — |
| Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece | United States | Contract manufacturer | — | — | — |
| Elmed, Inc. | United States | Repacker / relabeler | ELMED | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Orthomed Inc | United States | Repacker / relabeler | ORTHOMED INC | — | — |
| Surgix Medical, L.L.C. | United States | Repacker / relabeler | Bone Chisel | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Amnotec International Medical GmbH | Germany | Repacker / relabeler | — | — | — |
| MicroPort Orthopedics Global Supply Center Limited | China | Foreign exporter | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Jun 1985 | K851715 | 830/4 TO 848/7 VARIOUS TYPES CHISELS | Artiberia |
| 24 Nov 1982 | K823320 | DENTAL INSTRUMENTS - BONE CHISELS | Miltex, Inc. |
Official records: FDA product classification for EML · 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