Dental burs & diamonds: manufacturers and brands
190 companies make or specify dental burs among the 269 that list one with FDA, under 2,021 brand and model names. FDA has issued 48 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental bur manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| 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 | Zircon diamond burr set | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BruxZir Adjustment & Polishing Kit · BruxZir Bur Set 3/Pk · BruxZir Diamond Football Bur, 3/Pk · BruxZir Round Bur (018 mm), 3/Pk · +5 | 56 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | DISC | 30 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Brasseler shank extension · Densah Burs · Hager & Meissinger GmbH · Short Densah Burs · +2 | 94 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | AGDSC | 68 | 2026 |
| Shofu Inc | Japan | Maker | ROBOT CARBIDE · THE ARTISTIC COMPOSITE KIT | 96 | 2025 |
| Sybron Dental Specialties | United States | Maker | All Ceramic Logic Set · All-Purpose Esthetic Logic Set · Axis Carbide Burs · Barbed Broaches · +70 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Ultradent Comp. Finishing Bur Kit · Unicore Drill | 95 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | GRT063025 · GRT065030 · GRT085030 · GST083025 · +125 | 23 | 2025 |
| B.t.i. Biotechnology | Spain | Maker | — | 14 | 2024 |
| Dent4You AG | Switzerland | Maker | Alpen Diamond Instruments · Diatech Diamond Instruments · Alpen Carbide · Alpen Speedster | 5 | 2026 |
| Stryker | United States | Maker | — | 33 | 2024 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Round Burr | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | SOLO DIAMOND | 28 | 2026 |
| Young Innovations Inc | United States | Maker | Dental Cadre Bur 5 · Johnson Promident Polishers, Finishing Srips | 23 | 2025 |
| Keystone Dental Inc. | United States | Maker | Prima Dental Implant System · RENOVA Dental Implant System · RESTORE Dental Implant System · STAGE-1 Dental Implant System | 7 | 2024 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Dental Burs | 5 | 2026 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Maker | Guided Surgery CloseFit Drills & Accessories Kit · Guided Surgery Drills 18mm · Guided Surgery Drills, GS Pilot Drills, Anchoring Drills · Tip Drill | 3 | 2026 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | China | Maker | Burs · GUSROM | 3 | 2023 |
| Hager& Meisinger GmbH | Germany | Maker | MEISINGER Diamond Instruments · Singles · MEISINGER Rotary Steel Instruments · MEISINGER Rotary Tungsten Carbide Instruments · +8 | 14 | 2025 |
| Dentalez, Inc. | United States | Maker | Classique Diamond Burs | 9 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | CleanCut Extended Use Diamond · Extra-Fine Smoothing Diamond · Football Diamond · Interproximal Mosquito Diamond · +3 | 8 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Alpen · Alpen Diamond Instruments · Alpen Speedster Zr Plus · Alpen Z-Rex · +8 | 45 | 2022 |
| Osteomed, LLC | United States | Maker | Dental Burs | 26 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | Galaxy · REVEAL® | 8 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | OSD-1034-12C · OSD-1050-07S · OSD-1062-06S · OSD-1070-12S · +52 | 5 | 2023 |
| Tp Orthodontics, Inc. | United States | Maker | Debonding burs | 5 | 2022 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | LuxaPost Bohrer 1,25 · LuxaPost Bohrer 1,375 · LuxaPost Bohrer 1,5 · LuxaPost PS Intro USA | 4 | 2022 |
| Leone S.P.A. | Italy | Maker | BURS · DRILLS | 4 | 2025 |
| Garrison Dental Solutions LLC | United States | Maker | FitStrip | 3 | 2024 |
| ZimVie US Corp LLC | United States | Maker | Burs for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant Systems | 1 | 2026 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | DIAMOND BURS · Dental Burs(Diamond Burs/Carbide Burs), Rubber Diamond Polisher, Rubber Diamond Polisher · Infinity Endo Diamond Burs · Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Carborundum burr · Crestal Approach Drill I · Crestal Approach Drill II · Lateral Approach Drill III | 1 | 2026 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Diamond dental burs,NIC dental burs,SUPERLINE dental burs · Fliex · Zirconia cutting burs | 1 | 2025 |
| Bioline Dental Implant Systems Ltd | Israel | Maker | FG Diamond Dental Burs · FG Dental Burs | 1 | 2025 |
| Zumax Medical Co., Ltd. | China | Maker | Micro Needle Holder | 1 | 2026 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | BUR, DENTAL; profa dental bur | 1 | 2023 |
| Reliance Orthodontic Products, Inc. | United States | Maker | RENEW ADHESIVE REMOVAL BUR | 32 | 2021 |
| Bicon, LLC | United States | Maker | Latch Reamer · Pilot Drill | 18 | 2015 |
| CAMLOG Biotechnologies GmbH | Switzerland | Maker | A2050.2600 Drill for CT-tube (for A2002.2000), d 2.6 mm · A2050.2600 Template drill for placement of CT-tubes · A2050.2600 Template drill for placement of CT-tubes d 2.6 mm · A2050.2800 Drill for CT-tube (for A2222.2200), d 2.8 mm · +273 | 14 | 2020 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | DENTAL BUR | 11 | 1996 |
| Micerium S.P.A. | Italy | Maker | drill for locking system · MAS Ball Bur · MAS Drill · Pilot ball bur | 6 | 2011 |
| Basic Dental Implant Systems, Inc. | United States | Maker | HAND BONE DRILL | 6 | 2008 |
| Rolence Ent., Inc. | Taiwan | Maker | Dental Burs | 5 | 2009 |
| Medimecca Co., Ltd. | South Korea | Maker | HTD350 · HTD400 · HTD450 · HTD500 · +32 | 4 | 2020 |
| OT medical GmbH | Germany | Maker | Bone Tap · Bone Trephine · Cortical Drill · Final drill · +6 | 3 | 2016 |
| Storz AM Mark GmbH | Germany | Maker | Drill bit · Pilot drill · Tissue punch · Trephine | 2 | 2008 |
| Surgident Co., Ltd. | South Korea | Maker | Dental Bur · NLBC Drill · NLBC Stopper · Pilot Drill · +1 | 2 | 2019 |
| Cendres+Metaux SA | Switzerland | Maker | — | 2 | 2020 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Microcopy, Div. Neo-Flo, Inc. | United States | Maker | NeoDiamond · Cut Carbide · NeoBurr | 2 | 1989 |
| Zuga Medical, Inc. | United States | Maker | Burs for Zuga Dental Implant Systems | 2 | 2018 |
| SDS Swiss Dental Solutions AG | Switzerland | Maker | — | 2 | 2020 |
| Hi-Tec Implants | Israel | Maker | CSD · CSD-EX.IR · FSD · FSD-EX.IR · +19 | 1 | 1994 |
| B&L Biotech Co., Ltd. | South Korea | Maker | PT-1A · PT-1E · PT-2A · PT-2E · +2 | 1 | 2006 |
| Abracadabra Implants Ltd. | Israel | Maker | HPL39 - Hollow Polishing Bur 3.9mm · HPL45 - Hollow Polishing Bur 4.5mm · HPL63 - Hollow Polishing Bur 6.3mm · HPL75 - Hollow Polishing Bur 7.5mm | 1 | 2021 |
| DENTIN Implants Technologies Ltd. | Israel | Maker | Countersink · Drill / CHEAT Drill · Marking Drill · Surgical Trephine | 1 | 2012 |
| Directa AB | Sweden | Maker | Supra disc · ROTOSTAND | 1 | 2015 |
| Nova Implants | Israel | Maker | Conical Drills with External Irrigation · Countersink · Drill Extender · Drill External · +10 | 1 | 2015 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET CERADRILL · KOMET DENTAL STEEL BURS, KOMET DENTAL TUNGSTEN CARBIDE BURS, KOMET DENTAL CERAMIC BURS, SHANK EXTENSION · KOMET DENTAL DIAMOND INSTRUMENTS | 1 | 2007 |
| Arnold Tuber Industries | United States | Maker | DENTAL BURS | 1 | 2009 |
| Abrasive Technology, Inc. | United States | Maker | Priva · Prodia · Prodia Sport · Two Striper | 1 | 1990 |
| Ziacom Medical, S.L. | Spain | Maker | Ziacom | 1 | 2019 |
| Bioseal | United States | Maker | Dental Bur | 1 | 1988 |
| Sicat GmbH & Co. KG | Germany | Maker | SICAT ACCESSGUIDE | 1 | 2016 |
| SS White Burs LLC | United States | Maker | BLACK DIAMOND, GREAT WHITE Z, PIRANHA, REVELATION · SS WHITE CARBIDE BURS | 1 | 2008 |
| E. C. Moore Company, Inc. | United States | Maker | E.C. Moore | 1 | 1979 |
| Spring Health Products, Inc. | United States | Maker | Spring Diamonds | 1 | 1999 |
| A & M Instruments, Inc. | United States | Maker | A&M Diamond Burs, LeBlond, | 1 | 1983 |
| Osung Mnd Co Ltd | South Korea | Maker | DBGLK · DBGOK · DBINK · DBMEK · +685 | — | — |
| Zain's Medical Image | Pakistan | Maker | Bur, Dental · Kit, Dental Burs | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Bur · Bur for acrylics · Grinding · Laboratory burs for plastics · +4 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental Bur | — | — |
| TruAbutment Korea Co Ltd | South Korea | Maker | Base Reamer · Cone Reamer · Direct Screw Final Reamer · Direct Screw Initial Reamer · +2 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | DIAMOND BURS · Dental Burs(Diamond Burs/Carbide Burs), Endo Disinfection Box/Holder, Rubber Diamond Polisher · Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones | — | — |
| HSG-S Corp | United States | Maker | Durabraze · Barrel · Beveled Cylinder · Bud · +40 | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | Instrument, Diamond, Dental - HENRY SCHEIN - MICRODONT - DIAMOND BURS · Bur, Dental - MICRODONT; MICRODONT DENTAL CARBIDE BURS · Soft Bur | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Instrument, Diamond Coated · Dental Bur | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ORTHOMETRIC BUR | — | — |
| ACH Medical Co., Ltd. | South Korea | Maker | Diamond 3D drill · Diamond Ossteotomy drill | — | — |
| Medcave Private Limited | Pakistan | Maker | Bur Dental | — | — |
| Nordent MFG., Inc. | United States | Maker | — | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental diamond bur | — | — |
| Dentatus AB | Sweden | Maker | Dentatus Diamond Instruments · FD · CePo Pilot drills | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Dental diamond bur | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Bur | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | MANI DIA-BURS · MANI CARBIDE BURS · MANI STAINLESS BURS · MANI STAINLESS BURS HARD · +1 | — | — |
| DFS-Diamon GmbH | Germany | Maker | 200147 Finishing & polishing kit ceramics/composites · 50500 REDUCERS HP, pu: 2pcs · 50510 REDUCERS CA, pu: 2 pcs · 50520 REDUCERS HP-FG 1,6 mm, pu: 2 pcs · +43 | — | — |
| NTI Kahla GmbH Rotary Dental Instruments | Germany | Maker | All Ceramic Supermax · Bambino Series · Brix Diamond Disc · Brix HP diamond · +26 | — | — |
| Otto Leibinger GmbH | Germany | Maker | Trephine | — | — |
| Solventum US LLC | United States | Maker | Burs | — | — |
| Unique Instruments Inc. | United States | Maker | dental bur | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Shenzhen Forever Medical Devices Co., Ltd | China | Maker | Diamond burs · Carbide burs | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | BUR, DENTAL | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | dental Burs | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | VDEYA, Diamond Burs, Model FG,XL,2XL,RA,BR,BC,EX,WF,WR,SF,TC,SR,TF,SI,D1,TC,TF,CR,FO,VP,CD,SO,BC,TR · VDEYA, Tungsten Carbide Burs, Model FG, RA, XLD, X | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Dental Bur | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Bioclear Matrix Systems, LLC | United States | Maker | TruContact · True Contact 2 | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | Carbide Burs, Diamond Burs | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Carbon Burs | — | — |
| Intensiv SA | Switzerland | Maker | Intensiv Diamond Instruments FG and RA | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Markson SureFita · All Ceramic Set; All-Purpose Esthetic Set; Carbide Burs; Bur Block;Crown Removal Set;Endodontic Access Set; · Fiber Post Drill;IPR Set; Crown & Bridge set; Inlay/Onlay Set; Root Shaping Set; Finishing Set; Soft Tissue Trimmer; · Post Drills; Posterior Composite Set; Resin Sculpting Set;T&F Carbides; SoloGood | — | — |
| one day dental partner | South Korea | Maker | kage INSTRUMENT, DIAMOND, DENTAL | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | BUR, DENTAL | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Dental Burs ( Carbide Burs / Finishing Carbide Burs / Surgical Carbide Burs / Crown Cutter Burs ) · Dental Burs ( Diamond Burs ); · Dental Burs ( Diamond Burs Sets: Finishing and Polishing Set ); · Dental Burs ( Diamond Burs Sets: Preparation Set Plus+, Preparation Set, Cavity Set ); | — | — |
| MDT Micro Diamond Technologies Ltd | Israel | Maker | Dental Rotary Instruments · IPR Interproximal Reduction Burs · Dr. Care · Dr. Clear · +6 | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Maker | Dental Diamond burs Dental Carbide burs | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Bur, Dental | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Bur, Dental | — | — |
| Versah LLC | United States | Maker | C-Guides Sleeves · Densah Burs · G-Stop Keys · G-Stop Vertical Gauges · +7 | — | — |
| Dentech Corp. | Japan | Maker | BUR, DENTAL | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Carbon Burs | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Burs | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Maker | Diamond Bur · IPR Diamond strips fine · IPR Diamond strips medium · IPR Diamond strips superfine · +1 | — | — |
| Hager & Werken | Germany | Maker | SMOCLEAN | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Dental Burs (CARBIDE BURS, Dental Burs) | — | — |
| Accumedix, Inc. | United States | Maker | Blue Sky Bio Dental Bur | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Dental Burs | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Bur, Dental | — | — |
| BUSCH & CO. GmbH & Co. KG | Germany | Maker | DIAMONDS · EXCAVATING BURRS · FISSURE BURRS · INLAY BURRS · +2 | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Hans Korea | South Korea | Maker | ICT · ICT 2D LONG · ICT MICRO · ICT NANO · +5 | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT BURS, 1DERFUL BURS | — | — |
| Win Wings Corp. | Pakistan | Maker | BUR DENTAL | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | Blue Diamond Bur · Carbide Bur; Stainless Bur | — | — |
| Sino Ortho Limited | China | Maker | diamod burs | — | — |
| Dongguan Integrity Medical Instrument Co.,Ltd. | China | Maker | Blue Diamond Bur; Carbide Bur; Stainless Bur | — | — |
| Edenta Etablissement | Liechtenstein | Maker | NTI · DIAMOND + CARBIDE BURS · TC CUTTERS | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | HANGZHOU ANGSHENG ORTHODONTIC PRODUCTS CO. LTD | — | — |
| Dhef Inc. | Taiwan | Maker | DENTAL BUR | — | — |
| Funing Meitedental Factory | China | Maker | Diamond Burs | — | — |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | China | Maker | Dental Polish Bur | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | BUR, DENTAL | — | — |
| Diaswiss, S. A. | Switzerland | Maker | INSTRUMENT, DIAMOND, DENTAL · BUR, DENTAL | — | — |
| Precision Edge Surgical Products Company | United States | Maker | MICRO BUR 0.35MM · MICRO BUR 0.5MM · MICRO BUR 0.85MM · MICRO BUR 1.45MM · +3 | — | — |
| Dedeco International, Inc. | United States | Maker | Instrument Diamond Dental · Point Abrasive · Bur, Dental | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | Diamond burs | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Prima Dental Group | United Kingdom | Maker | Predator Zirconia Diamonds · Prima Classic Diamonds | — | — |
| Verdent Ltd. | Poland | Maker | Verdent | — | — |
| Cynosure LLC | United States | Maker | Roto-Pro, Non-Clogging Bur, Dental Bur | — | — |
| puracon GmbH | Germany | Maker | Dental Bur | — | — |
| Zentro Enterprise Pvt. Ltd. | India | Maker | BUR, DENTAL | — | — |
| CeramTec Schweiz GmbH | Switzerland | Maker | Zeramex Dental Implant System | — | — |
| Hopf Ringleb & Co GmbH & Cie | Germany | Maker | DIAMOND INSTRUMENT · HORICO | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | Diamond Burs, Carbide Burs | — | — |
| Sphinx Tools Ltd | Switzerland | Maker | FibreKor | — | — |
| ACURATA GMBH & CO. KGaA | Germany | Maker | Acurata | — | — |
| EOCA MD Pty Limited | Australia | Maker | IPR Interproximal Reduction Burs | — | — |
| Evidence Implant Inc. | South Korea | Maker | SD2207 SD2212 SD2214 SD2215 SD2807 SD2812 SD2814 SD2815 SD3507 SD3512 SD3514 SD3515 SD4215 | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | Diamond bur GSAP 2,3P-8C | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Mothers Medica Private Limited | India | Maker | MM BURS · Nanoalign | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Reco-Dent International Co., Ltd. | Taiwan | Maker | Dental Diamond Instrument · Dental Bur | — | — |
| Hufschmied Zerspanungssysteme GmbH | Germany | Maker | Carbide Dental Burs · Dental Burs | — | — |
| Strauss & Co. | Israel | Maker | Strauss & Co. Burs | — | — |
| Yammi Hummingbird Medical Technology (Suzhou) Co., Ltd. | China | Maker | DIAMOND BURS | — | — |
| CrossTech Diamond Tools Co.,Ltd | Thailand | Maker | Crosstech | — | — |
| CTC(India) Private Limited | India | Maker | CTC | — | — |
| Dr Hopf GmbH and Co KG | Germany | Maker | — | — | — |
| Gaofeng Medical Equipment (Wuxi) Co., Ltd | China | Maker | Carbide Burs | — | — |
| Guangdong Rotary Art Equipment Co., Ltd. | China | Maker | Dental Burs | — | — |
| Henan Dian Tong Dental Material Co.,Ltd. | China | Maker | Dental burs | — | — |
| Lasco Diamond Products, Inc. | United States | Maker | Lasco Diamond Bur | — | — |
| Muller India Private Limited | India | Maker | PreciDent | — | — |
| Ningbo Sinyuan Bur & Tool Co.,Ltd. | China | Maker | Dental Burs | — | — |
| Sinyuan Dental (Thailand) Co.,Ltd. | Thailand | Maker | Dental Burs | — | — |
| Taizhou Proburrs Medical Technology Co., LTD. | China | Maker | DENTAL BURS | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| WILSON (Shanghai) Medical Device Co., Ltd | China | Maker | Wilson Brand Milling Tool | — | — |
| Xenopus Inc. | Canada | Maker | Tri Hawk | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Zonefly Medical Devices Co., Ltd. | China | Maker | — | — | — |
| Dentex Dental Industrial Corp | Taiwan | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Frank Dental GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Icp, Inc. | United States | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| North Bel Intl. S.r.l. | United States | Maker | — | — | — |
| Shaanxi Hanrui Med-Tech Co., Ltd. | China | Maker | — | — | — |
| Shenzhen Jinzhou Precision Technology Corp. | China | Maker | — | — | — |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Inter-Med, Inc. | United States | Contract manufacturer | Impact Air 45 Surgical Bur | 7 | 2026 |
| American Orthodontics | United States | Contract manufacturer | Bur Kit · Carbide Bur · Diamond Bur | 44 | 2026 |
| Implant Direct | United States | Manufacturer | Chairside bur block | 24 | 2023 |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| Lares Research | United States | Manufacturer | Cybercut Diamond Dental Bur · Cybercut Carbide Dental Bur | 8 | 2022 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL DIAMOND · DENTAL BUR | 5 | 2022 |
| Keystone Industries | United States | Contract manufacturer | Prehma Carbide Burs | 2 | 2025 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| Dent Zar, Inc. | United States | Repacker / relabeler | DENTAL DIAMOND INSTRUMENTS | 12 | 1996 |
| Hu-Friedy Mfg Co., LLC | United States | Contract manufacturer | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| CNC Manufacturing, Inc. | United States | Manufacturer | Bur, Dental | 5 | 2007 |
| Dentamerica | United States | Repacker / relabeler | DENTAL BUR | 4 | 2010 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | EVA | 4 | 2004 |
| Oco Biomedical | United States | Manufacturer | DENTAL BUR | 4 | 2013 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Jarit · Miltex · Padgett | 2 | 2014 |
| G&H Wire Company | United States | Contract manufacturer | N/A | 2 | 2008 |
| Hager Worldwide, Inc. | United States | Manufacturer | — | 2 | 2005 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | DB Orthodontic Rotary Dental Burs | 2 | 2010 |
| World Class Technology Corporation | United States | Manufacturer | Diamond Disc · Interproximal Reduction (IPR) | 1 | 2019 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | A. Titan | 1 | 2006 |
| Engineered Endodontics | United States | Repacker / relabeler | EndoScout Diamond Access bur · EndoScout Multi Use Bur · EndoScout Z style Bur · Munce Discovery Burs · +1 | 1 | 2019 |
| Valplast Intl. Corp. | United States | Manufacturer | Valplast Bur | 1 | 2006 |
| Sotera Health LLC | United States | Contract manufacturer | BrasselerLGI¿ · SteriPrep¿ | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA FG #36823 Fine Grit Flame Shaped Diamond Burs, 10/Pk · Valdent USA FG #36823SC, TR-22SC, Needle Shaped Super Coarse Grit Diamond Burs, 10/Pk · Valdent USA FG #37918 Fine Grit Needle Shaped Diamond Burs, 10/Pk · Valdent USA FG #37923 Fine Grit Flame Shaped Diamond Burs, 10/Pk · +106 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | BUR HOLDER · BUR RETAINER CASE · METAL BURS HOLDER · PLASTIC HOLDER · +7 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS · angelus Bur, Dental · dentq Bur, Dental · torino Bur, Dental | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Instrument · Diamond Burs | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | INSTRUMENT, DIAMOND, DENTAL · BUR, DENTAL | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Diamond Bur · Patterson Carbides & Diamonds | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Endo · bur dental | — | — |
| STERIS Corporation | United States | Contract sterilizer | WhiteBurr3283 (WH,CH1) - SS White Carbide Burs | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Abrasive Points and Trimmers · Bono Trimmer · Debonding burs · Diamond burs · +12 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Baby Mosquito and Regular · Carbide Finishing Bur · Life Saver bur · White Stone | — | — |
| Premium Plus Dental | United States | Lister | PREMIUM PLUS · Premium Plus Polising Burs | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | Luster ® / not applicable | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent Bur Kit | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Contract manufacturer | Bur | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Diamond Burs | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Finishing & Polishing | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | BURS | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | BUR, DENTAL | — | — |
| ArtCraft Dental, Inc. | United States | Repacker / relabeler | Metal Buster · The Flame · Zirconia Buster · 558S · +1 | — | — |
| Aragogamma, S.L. | Spain | Contract sterilizer | — | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Bur, Dental | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | OSD-1434-04C | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL BUR · DIAMIOND BUR | — | — |
| K&S Instruments | United States | Repacker / relabeler | Alden Surgical Bur | — | — |
| Dental Engineering Laboratories | United States | Repacker / relabeler | GG-3M · TFRK-MT | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Dia-Burs | — | — |
| Saga Dental Supply A | Norway | Contract manufacturer | Bur · Diamond Bur IPR | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Garreco, LLC. | United States | Manufacturer | Garreco | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Maverick Dental, LLC | United States | Repacker / relabeler | Typhoon · Eliminator · Excalibur · Terminator | — | — |
| Smyles Above Innovations, Inc | United States | Contract manufacturer | IrriGUIDE Seating Bur · IrriGUIDE Trimming Bur | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | diamond burs | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | — | — | — |
| Drendel & Zweiling DIAMANT GmbH | Germany | Foreign exporter | DENTAL DIAMONDS · ECOLINE | — | — |
| TriRock Dental LLC | United States | Repacker / relabeler | TriRock Dental | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Endo Direct, LLC | United States | Repacker / relabeler | — | — | — |
| SDS Dental Supply Inc. | United States | Repacker / relabeler | Dental Bur, Burs Dental | — | — |
| BGS Beta-Gamma-Service GmbH & Co KG | Germany | Contract sterilizer | — | — | — |
| Imperial Trading Limited | Barbados | Foreign exporter | — | — | — |
| Innopex Limited | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental burs are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Dental BurEJL | 1 | 872.3240 | 171 | 27 |
| Dental Diamond InstrumentDZP | 1 | 872.4535 | 63 | 21 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Apr 2012 | K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. | DZP Dental Diamond Instrument |
| 20 Jun 2008 | K080687 | SMARTBURS | SS White Burs LLC | EJL Dental Bur |
| 29 Jun 2007 | K071352 | CERADRILL | Gebr. Brasseler GmbH & Co. KG | EJL Dental Bur |
| 3 Aug 2006 | K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | B.t.i. Biotechnology | EJL Dental Bur |
| 16 Sep 1994 | K943841 | SOPHOS DENTAL DIAMOND | Sophos Technologic | DZP Dental Diamond Instrument |
| 29 Aug 1994 | K940908 | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | Dunhall Pharmaceuticals, Inc. | DZP Dental Diamond Instrument |
| 1 Aug 1994 | K943273 | TRI HAWK BUR, FG BUR | Tri Hawk Corp. | EJL Dental Bur |
| 10 Feb 1994 | K926205 | MONOSTERYL | Utensili Super Abrasivi | EJL Dental Bur |
| 3 Feb 1994 | K934981 | DENTAL DRILL | Eare Consulting Service | DZP Dental Diamond Instrument |
| 27 Jul 1993 | K923883 | DENTAL OR SURGICAL BUR | Stratum Dental Technologies, Inc. | EJL Dental Bur |
| 16 Mar 1993 | K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | DZP Dental Diamond Instrument |
| 28 Apr 1992 | K921406 | SILICONT BUR BLOCK | Innovators, Inc. | EJL Dental Bur |
| 25 Mar 1992 | K920243 | SMART BURS TOTAL CARBIDES | Vermont Diamond Instruments | EJL Dental Bur |
| 14 Jan 1992 | K913651 | MANI DIA-BURS | The Lahr Consulting Group, Inc. | DZP Dental Diamond Instrument |
| 16 Sep 1991 | K911208 | TIN COATED DENTAL BURS | Surgical Precision Instruments, Corp. | EJL Dental Bur |
| 23 May 1991 | K910794 | SMALL INSTRUMENT STERILIZATION/BUR BOX | Brevet, Inc. | EJL Dental Bur |
| 13 Jul 1990 | K901967 | DENDIA WERK BURS AND CUTTING DISCS | Micro-Aire Surgical Instruments, Inc. | DZP Dental Diamond Instrument |
| 9 Jul 1990 | K901262 | F.G. LASER (DENTAL BUR) | Diamond Rotary and Carbide Intl. | DZP Dental Diamond Instrument |
| 3 Apr 1990 | K900089 | FG DIAMOND BURRS | Kab Gloves Unltd. | DZP Dental Diamond Instrument |
| 11 Aug 1989 | K893844 | 3D DENTAL DIAMOND ROTARY INSTRUMENTS | Lustgarten Multi-Tech International, Inc. | DZP Dental Diamond Instrument |
| 13 Feb 1989 | K885233 | NOVA DIAMOND | Microcopy, Div. Neo-Flo, Inc. | DZP Dental Diamond Instrument |
| 21 Jun 1988 | K882183 | DENTAL BURS | Tri-Stage, Inc. | EJL Dental Bur |
| 9 Mar 1988 | K880179 | BEAVERS' DENTAL DIAMOND INSTRUMENTS | Beavers Dental, Div. Sybron Canada, Ltd. | DZP Dental Diamond Instrument |
| 3 Dec 1987 | K873698 | STERILIZED DENTAL BIT PACKAGING | Florida Diamond Instruments Corp. | EJL Dental Bur |
| 18 May 1987 | K871639 | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. | DZP Dental Diamond Instrument |
| 26 Aug 1986 | K863097 | CB BUR | Beavers Dental, Div. Sybron Canada, Ltd. | EJL Dental Bur |
| 25 Mar 1986 | K854691 | DIAMOND BURS-HANDPIECE | Almore Intl., Inc. | EJL Dental Bur |
| 25 Mar 1986 | K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Almore Intl., Inc. | EJL Dental Bur |
| 27 Dec 1985 | K854347 | HYBRID POINTS | Shofu Inc | DZP Dental Diamond Instrument |
| 21 May 1985 | K842720 | BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL | Penn-Med Technology, Inc. | EJL Dental Bur |
| 29 Dec 1983 | K833598 | LEBLOND DIAMOND DENTAL BUR | A & M Instruments, Inc. | EJL Dental Bur |
| 4 Oct 1983 | K833038 | SUMMA DISK | Shofu Inc | DZP Dental Diamond Instrument |
| 4 Oct 1983 | K832856 | GINGI CURETTAGE DIAMOND POINTS | Shofu Inc | DZP Dental Diamond Instrument |
| 29 Sep 1983 | K832855 | TPE DIAMOND POINTS | Shofu Inc | DZP Dental Diamond Instrument |
| 24 Nov 1982 | K823314 | DENTAL INSTRUMENTS | Miltex, Inc. | EJL Dental Bur |
| 30 Dec 1980 | K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. | EJL Dental Bur |
| 30 Dec 1980 | K802988 | JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS | Swiss American Metal Craft Corp. | EJL Dental Bur |
| 30 Dec 1980 | K802987 | JOTA DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | DZP Dental Diamond Instrument |
| 30 Dec 1980 | K802984 | MEISINGER DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | DZP Dental Diamond Instrument |
| 20 Aug 1980 | K801886 | BURR, DENTAL | Aesculap Instruments Corp. | EJL Dental Bur |