Surgical devices · 21 CFR 872 Subpart E
Surgical Osteotome Chisel
FDA device type “Chisel, Osteotome, Surgical”.
- Companies listing it
- 11491 makers
- Brands and models
- 206
- 510(k) clearances
- 40 in five years
- FDA name
- Chisel, Osteotome, Surgical
510(k) clearances per year, 1976–2026
Companies that list EMM
114 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Straumann Dental Implant System | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Ossvis Co., Ltd. | South Korea | Maker | Convex Osteotome | 7 | 2024 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Premier Dental Products Company | United States | Maker | PREMIER OSTEOTOME CHISEL | 28 | 2026 |
| Dentium USA | United States | Maker | RS142435 · RS203235 · RS263635 · XOCK · +16 | 23 | 2022 |
| DIO Corporation | South Korea | Maker | DIO Osteotome · DIO Osteotome Kit · DIO Sinus Lift Kit · Wave ST Osteotome | 14 | 2023 |
| CAMLOG Biotechnologies GmbH | Switzerland | Maker | J5417.2800 Pre-Osteotome SCREW-LINE, straight convex d 1.7-2.8 mm · J5418.3300 Osteotome SCREW-LINE, straight convex d 3.3 mm · J5418.3310 Osteotome SCREW-LINE, angled convex d 3.3 mm · J5418.3800 Osteotome SCREW-LINE, straight convex d 3.8 mm · +26 | 14 | 2020 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| OT medical GmbH | Germany | Maker | OT-F³ Osteotome Tip · OT-F³ Trial Fit Gauge | 3 | 2016 |
| Storz AM Mark GmbH | Germany | Maker | Osteotome | 2 | 2008 |
| Suncoast Dental Corp. | United States | Maker | BB Straight/Offset Osteotome · BS Straight/Offset Osteotome · Channel Former D1,2,3,4 · D1,2,3,4 Straight/Offset Osteotome · +11 | 2 | 1981 |
| Kirwan Surgical Products, Inc. | United States | Maker | Chisel · Osteotome | 1 | 1990 |
| Osung Mnd Co Ltd | South Korea | Maker | BOC22 · BOC28 · BOC35 · BOC35R · +11 | — | — |
| ErgoDenta ApS | Denmark | Maker | Bone Spreader (set of 6 including hammer & cassette) · Condenser Offset (Set of 7 including hammer & cassette) · Condenser Straight (Set of 7 including hammer & cassette) · Osteotome Offset (set of 5 including hammer & cassette) · +1 | — | — |
| Zain's Medical Image | Pakistan | Maker | Osteotome · Osteotome Spade Tip | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Osteotome Bayonet Concave 2.2mm · Osteotome Bayonet Concave 2.7mm · Osteotome Bayonet Concave 3.2mm · Osteotome Bayonet Concave 3.7mm · +16 | — | — |
| Signor Seven International | Pakistan | Maker | Angled, Sinus Osteotomes L-Key Stops Concave Diameter 2.6 SKU OS-1006-P · Angled, Sinus Osteotomes L-Key Stops Concave Diameter 3.1 SKU OS-1007-P · Angled, Sinus Osteotomes L-Key Stops Concave Diameter 3.8 SKU OS-1008-P · Angled, Sinus Osteotomes L-Key Stops Concave Diameter 4.5 SKU OS-1009-P · +8 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| STERIS Corporation | United States | Maker | Snowden-Pencer Osteotome Chisel (WM-FE,RR) · V. Mueller Osteotome Chisel (ST-SD) | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Osteotome | — | — |
| Pomee Corporation | Pakistan | Maker | Concave · Convex · Tapered | — | — |
| Medcave Private Limited | Pakistan | Maker | Chisel · Osteotome | — | — |
| Panorama International | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Lacigrus International | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | CHISEL OSTEOTOME SURGICAL | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Otto Leibinger GmbH | Germany | Maker | Bone Scraper · Chisel · Osteotome | — | — |
| Unique Instruments Inc. | United States | Maker | osteotome | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | OSTEOTOME | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Harf Industries | Pakistan | Maker | Membrane Placement Instrument | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | dental chisel | — | — |
| Surgiscape | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Choose Surgical Instruments | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Medline Industries, LP | United States | Maker | Medline / Konig Chisel, Osteotome, Surgical | — | — |
| Teleflex | United States | Maker | Pilling | — | — |
| Trimed Pvt Ltd | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROWN ECO | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Aesculap | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Mian Shahid Corp. | Pakistan | Maker | — | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| S.R.R. Surgical Co | Pakistan | Maker | Dental osteotomes · Nasal Chisels · Osteotomes | — | — |
| Win Wings Corp. | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | CAPENER CHIESEL | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | Osteotomes | — | — |
| Asanus Medizintechnik GmbH | Germany | Maker | ASANUS | — | — |
| SITEC (Pvt.) Ltd. | Pakistan | Maker | Chisel, Osteotome, Dental Surgical | — | — |
| Avilign Medical | Pakistan | Maker | CHISEL OSTEOTOME SURGICAL | — | — |
| Fetzer Medical GmbH & Co.KG | Germany | Maker | osteotome | — | — |
| Meister Surgical Instruments | Pakistan | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | China | Maker | Dental Implant Bone Expander | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| GSource LLC | United States | Maker | Chisel/Osteotome, Surgical | — | — |
| NN Inc Power Solutions | United States | Maker | CHISEL, OSTEOTOME, SURGICAL | — | — |
| IAA Surgical Instruments Co | Pakistan | Maker | OSTEOTOME | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | 5027850U0 | — | — |
| SUBAN Instruments Germany GmbH | Germany | Maker | — | — | — |
| Hermann Mueller Medizintechnik GmbH | Germany | Maker | — | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| RUDISCHHAUSER SURGICAL INSTRUMENTS MANUFACTURING GmbH | Germany | Maker | IN1539 | — | — |
| 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 | — | — | — |
| e.l. zepf GmbH | Germany | Maker | — | — | — |
| Elmed Instruments (Pvt) Ltd | Pakistan | Maker | — | — | — |
| Eltek Instruments (Pvt.) Ltd. | Pakistan | Maker | — | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| Fetzer Surgical, LLC | United States | Maker | — | — | — |
| G. Hipp & Sohn GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| HGR Instrumente GmbH | Germany | Maker | — | — | — |
| KAPP Surgical GmbH | Germany | Maker | — | — | — |
| Oertel Medical GmbH | Germany | Maker | — | — | — |
| Oertel Medizintechnik | Germany | Maker | — | — | — |
| RZ Medizintechnik GmbH | Germany | Maker | — | — | — |
| Stengelin Medical | Germany | Maker | — | — | — |
| Stork Instrumente GmbH | Germany | Maker | — | — | — |
| Willy Storz GmbH. | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Surgical Instruments - Chisel | 23 | 2025 |
| Bicon, LLC | United States | Manufacturer | Osteotome | 18 | 2015 |
| Biomet Microfixation | United States | Manufacturer | Chisel · Osteotome | 8 | 2021 |
| Jedmed Instrument Co. | United States | Repacker / relabeler | Osteotome Chisel | 4 | 1981 |
| Aesculap, Inc. | United States | Lister | OSTEOTOME | 2 | 2006 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Chisel Osteotome | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Aesculap | — | — |
| E A Beck & Company | United States | Repacker / relabeler | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | multiple | — | — |
| K&S Instruments | United States | Repacker / relabeler | Alden Surgical Chisel · Alden Surgical Osteotome | — | — |
| ambler surgical | United States | Repacker / relabeler | — | — | — |
| Med Saver, Inc. | United States | Repacker / relabeler | MSI Precision Specialty Instruments | — | — |
| Boss Instruments Ltd | United States | Repacker / relabeler | — | — | — |
| Surgical Instrument | United States | Repacker / relabeler | CHISEL, OSTEOTOME, SURGICAL | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Accurate Surgical & Scientific Instruments Corp | United States | Repacker / relabeler | ASSI.ATK414026, ASSI.ATK414126, ASSI.ATK691226 | — | — |
| Merced Medical, Inc. | United States | Lister | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
| Wexler Surgical Inc. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 6 Nov 1996 | K963897 | STERI-OSS SINUS AUGMENTATION KIT | Steri-Oss, Inc. |
| 12 Feb 1987 | K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | New England Surgical Instrument Corp. |
| 11 Jun 1985 | K851714 | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS | Artiberia |
| 15 Nov 1976 | K760959 | SURGICAL CHISEL | American Safety Equipment Corp. |
Official records: FDA product classification for EMM · 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