Prosthetic devices · 21 CFR 872 Subpart D
Dental Bur
FDA device type “Bur, Dental”.
- Companies listing it
- 241171 makers
- Brands and models
- 1,166
- 510(k) clearances
- 270 in five years
- FDA name
- Bur, Dental
510(k) clearances per year, 1976–2026
Companies that list EJL
241 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 |
| 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 · +30 | 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 Carbide · Alpen Speedster | 5 | 2026 |
| Stryker | United States | Maker | — | 33 | 2024 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Round Burr | 7 | 2025 |
| Young Innovations Inc | United States | Maker | Dental Cadre Bur 5 | 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 Rotary Steel Instruments · MEISINGER Rotary Tungsten Carbide Instruments · myplant two Conical Reamer · myplant two Drill Extension · +7 | 14 | 2025 |
| Den-Mat Holdings, LLC | United States | Maker | Polishing Cup · Polishing Point | 8 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | ALPEN SPEEDSTER · Alpen® Carbide · Alpen® SteriX · Diatech Carbide · +1 | 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 |
| 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 | 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 |
| Bioline Dental Implant Systems Ltd | Israel | Maker | 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 | 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 | 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 | 1 | 2007 |
| Arnold Tuber Industries | United States | Maker | DENTAL BURS | 1 | 2009 |
| 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 | SS WHITE CARBIDE BURS | 1 | 2008 |
| E. C. Moore Company, Inc. | United States | Maker | E.C. Moore | 1 | 1979 |
| Osung Mnd Co Ltd | South Korea | Maker | BL012C4 · BL012EF2 · BL012EF4 · BL012EF6 · +84 | — | — |
| 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 | Dental Burs(Diamond Burs/Carbide Burs), Endo Disinfection Box/Holder, Rubber Diamond Polisher · Silicon Polisher/Diamond Polisher/Tungsten Cutter/Finishing Stones | — | — |
| 3R Industria e Comercio Ltda | Brazil | Maker | Bur, Dental - MICRODONT; MICRODONT DENTAL CARBIDE BURS · Soft Bur | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | 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 | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental diamond bur | — | — |
| Dentatus AB | Sweden | Maker | 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 CARBIDE BURS · MANI STAINLESS BURS · MANI STAINLESS BURS HARD · MI Stainless Burs | — | — |
| DFS-Diamon GmbH | Germany | Maker | — | — | — |
| NTI Kahla GmbH Rotary Dental Instruments | Germany | Maker | NTI · NTI Soft Tissue Trimmer · NTI Tri-Fissure · T&F Carbides · +1 | — | — |
| 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 | 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, 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 | — | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | Carbide Burs, Diamond Burs | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Carbon Burs | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | 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 | — | — |
| 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 | Dr. Care · Dr. Clear · Dr. Friendly · Helix · +4 | — | — |
| 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 | IPR Interproximal Reduction Burs | — | — |
| 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 | EXCAVATING BURRS · FISSURE BURRS · INLAY BURRS · PLUG FINISHING AND BURNISHING BURRS · +1 | — | — |
| 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 | 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 | 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 | Bur, Dental | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Prima Dental Group | United Kingdom | Maker | — | — | — |
| 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 | 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 | — | — |
| 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 | — | — | — |
| Mothers Medica Private Limited | India | Maker | MM BURS · Nanoalign | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Reco-Dent International Co., Ltd. | Taiwan | Maker | 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 | — | — |
| 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 | — | — | — |
| Devemed 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 Carbide Dental Bur | 8 | 2022 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | DENTAL BUR | 5 | 2022 |
| Keystone Industries | United States | Contract manufacturer | Prehma Carbide Burs | 2 | 2025 |
| 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 |
| Oco Biomedical | United States | Manufacturer | DENTAL BUR | 4 | 2013 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex | 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 |
| Abrasive Technology, Inc. | United States | Manufacturer | Prodia | 1 | 1990 |
| 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 #52C Egg Shaped Standard Carbide Bur · Valdent USA #61A Flame Shaped Standard Carbide Bur · Valdent USA #61T Titanium Nitride Coated · Valdent USA #82T Cone Shaped · +85 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental carbide bur · dental carbide cutter · dental diamond burs · dental diamond disc · +3 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | angelus Bur, Dental · dentq Bur, Dental · torino Bur, Dental | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Diamond Burs | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | BUR, DENTAL | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Carbides & Diamonds | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | bur dental | — | — |
| STERIS Corporation | United States | Contract sterilizer | WhiteBurr3283 (WH,CH1) - SS White Carbide Burs | — | — |
| HSG-S Corp | United States | Manufacturer | Barrel · Beveled Cylinder · Bud · Diablo · +39 | — | — |
| 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 Polising Burs | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | — | — | — |
| GoldenDent | United States | Repacker / relabeler | GoldenDent Bur Kit | — | — |
| 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 | — | — | — |
| 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 | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | OSD-1434-04C | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL 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 | — | — | — |
| 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 | — | — | — |
| Maverick Dental, LLC | United States | Repacker / relabeler | 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 | — | — | — |
| 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 | — | — | — |
| SDS Dental Supply Inc. | United States | Repacker / relabeler | Dental Bur, Burs Dental | — | — |
| BGS Beta-Gamma-Service GmbH & Co KG | Germany | Contract sterilizer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Jun 2008 | K080687 | SMARTBURS | SS White Burs LLC |
| 29 Jun 2007 | K071352 | CERADRILL | Gebr. Brasseler GmbH & Co. KG |
| 3 Aug 2006 | K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | B.t.i. Biotechnology |
| 1 Aug 1994 | K943273 | TRI HAWK BUR, FG BUR | Tri Hawk Corp. |
| 10 Feb 1994 | K926205 | MONOSTERYL | Utensili Super Abrasivi |
| 27 Jul 1993 | K923883 | DENTAL OR SURGICAL BUR | Stratum Dental Technologies, Inc. |
| 28 Apr 1992 | K921406 | SILICONT BUR BLOCK | Innovators, Inc. |
| 25 Mar 1992 | K920243 | SMART BURS TOTAL CARBIDES | Vermont Diamond Instruments |
| 16 Sep 1991 | K911208 | TIN COATED DENTAL BURS | Surgical Precision Instruments, Corp. |
| 23 May 1991 | K910794 | SMALL INSTRUMENT STERILIZATION/BUR BOX | Brevet, Inc. |
| 21 Jun 1988 | K882183 | DENTAL BURS | Tri-Stage, Inc. |
| 3 Dec 1987 | K873698 | STERILIZED DENTAL BIT PACKAGING | Florida Diamond Instruments Corp. |
| 26 Aug 1986 | K863097 | CB BUR | Beavers Dental, Div. Sybron Canada, Ltd. |
| 25 Mar 1986 | K854691 | DIAMOND BURS-HANDPIECE | Almore Intl., Inc. |
| 25 Mar 1986 | K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Almore Intl., Inc. |
| 21 May 1985 | K842720 | BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL | Penn-Med Technology, Inc. |
| 29 Dec 1983 | K833598 | LEBLOND DIAMOND DENTAL BUR | A & M Instruments, Inc. |
| 24 Nov 1982 | K823314 | DENTAL INSTRUMENTS | Miltex, Inc. |
| 30 Dec 1980 | K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. |
| 30 Dec 1980 | K802988 | JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS | Swiss American Metal Craft Corp. |
| 20 Aug 1980 | K801886 | BURR, DENTAL | Aesculap Instruments Corp. |
| 21 Apr 1978 | K780641 | DENTAL ROTARY CARBIDE BURS 76EJL | Teledyne Densco |
| 3 Aug 1977 | K771347 | R&R ALSTON CARBIDE BURS | Ransom & Randolph. LLC. |
| 15 Jul 1977 | K771214 | SUPERFINE DIAMONDS | Den-Mat Corp. |
| 16 Mar 1977 | K770469 | CUTTER TUNGSTEN CARBIDE BURS | Cutter Laboratories, Inc. |
| 24 Jan 1977 | K770093 | DENTAL BURS | The S. S. White Co. |
| 15 Nov 1976 | K760986 | CARBIDE DENTAL BURS | Adp Intl., Inc. |
Official records: FDA product classification for EJL · 21 CFR 872.3240.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026