Surgical drills & motors: manufacturers and brands
176 companies make or specify dental surgical drills among the 237 that list one with FDA, under 2,345 brand and model names. FDA has issued 105 510(k) clearances in this category, 16 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental surgical drill 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 · EUROPOST · EXCELPOST · coDiagnostiX · +1 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Drills · GATES · LARGO · Contra-angle | 148 | 2026 |
| ARUM DENTISTRY Co., Ltd | South Korea | Maker | Anchor Drill · Bone Expander Drill · Bone Flattening Drill · Bone Profiler · +23 | 17 | 2025 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Auto-Max · Bottom Drill · Carbide Round Bur · CASA Drill · +18 | 30 | 2026 |
| Nakanishi, Inc. | Japan | Maker | E-TYPE SPEED REDUCER CONTRA ANGLE · FC-78 · SG20 · SG20M · +127 | 37 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Trefoil Clinical Screw · TREFOIL Framework · Surgical Handpiece | 94 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Anchor Drill · Anchor Screw · AutoBone Collector · Bone Compaction Drill · +41 | 68 | 2026 |
| DiaDent Group International | South Korea | Maker | Gate Drills · Peeso Reamers | 24 | 2026 |
| Elos Medtech Pinol A/S | Denmark | Maker | Nobel Replace, Nobel Active, Nobel Direct, Branemark System | 14 | 2026 |
| Izenimplant Co., Ltd. | South Korea | Maker | Bone Profiler (Model: SBP41, SBP46, SBP56, SBP76) · BT Profiler for Healing Abutment (Model: BTP50M, BTP50R) · Cortical Drill (Model: CD3FXF30, CD3FNF30, CD4FF35, CD4FF40, CD4FF45, CD4FF50, CD4FF55, CD4FF60, CD4FF70) · Dental T-Shaper (Model: DTSD18) · +47 | 8 | 2026 |
| GC America Inc. | United States | Maker | GC Fiber Post Drill | 137 | 2026 |
| Cowellmedi Co., Ltd. | South Korea | Maker | — | 14 | 2025 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Ai-surgery, Surgic smart · Piezo Bone Surgery · Surgery-X, Surgery-X LED, Surgic Touch, Surgic Touch LED · Ultrasurgery · +1 | 12 | 2025 |
| Ossvis Co., Ltd. | South Korea | Maker | Bone Profile Drill · Cortical Drill · Cortical Drill S2 · Crestal Drill · +25 | 7 | 2024 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Dental Electrical Motors; C-PUMA MASTER · Dental Implantation Systems; C-Sailor Pro | 6 | 2025 |
| Chengdu Besmile Medical Technology Co., Ltd. | China | Maker | Drill | 5 | 2026 |
| Stryker | United States | Maker | CORE System · Delta System · Pi Drive 2 Motor · Pi Drive 2 Plus Motor · +7 | 33 | 2024 |
| Noris Medical Ltd. | Israel | Maker | — | 8 | 2025 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Abutment Screw Reverse Drill · Bone Profiler · Bone Profiler Post Implant · Bone Profiler Pre-Implant · +35 | 7 | 2025 |
| Implant Direct | United States | Maker | Guided Surgery Kit · Surgical Drills | 24 | 2023 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | PIEZOART · Traus SUS20 | 16 | 2026 |
| Mectron S.P.A. | Italy | Maker | combi touch · MT-Bone · MT11L-10 · MT11R-10 · +6 | 11 | 2025 |
| Shinhung Mst Co., Ltd. | South Korea | Maker | AD10 · CDR · CDW / Cortical Drill · FDR · +215 | 7 | 2023 |
| Keystone Dental Inc. | United States | Maker | Bone Profiler w/Guide Pin for External Hex Implants · Bone Profiler with Centering Pin for PrimaConnex Implants · Countersink Drill for 3.75 Hex Implants · Countersink Drill for Prima Implants · +27 | 7 | 2024 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Surgical Drive System (model: ES70, ES90, E8) · Surgical Drive System ES70 Kit (model: ES70 K1, ES70 K2) · Surgical Drive System ES90 Kit (model: ES90 K1, ES90 K2, ES90 K3) | 5 | 2026 |
| Satelec - Acteon Group | United States | Maker | Bone cutting Instrument/Accessories · Craniomaxillofacial Surgery Tips: SL3 -- BS6 XXL -- BS4 --SL2 -- SL1 -- BS2R XL -- BS2L XL -- BS1 XXL -- BS1L -- BS1RD · Drill, Bone , Powered · Drill, Bone, Powered · +11 | 18 | 2024 |
| Neobiotech Co., Ltd. | South Korea | Maker | Accessory KIT · All-in-One Remover KIT · ALX Bone Trimmer · ALX Margin Profile · +93 | 17 | 2024 |
| InnoBioSurg Co.,Ltd | South Korea | Maker | AMII GPS Depth Drill · AMII GPS Drill · AMII GPS Final Drill · AMII GPS Initial Drill · +37 | 15 | 2022 |
| Hager& Meisinger GmbH | Germany | Maker | Benex Twist Drills · MEI CT · MEI Glide · MEI K-Files · +13 | 14 | 2025 |
| Biotem Co., Ltd. | South Korea | Maker | Cortical Drill · Drill Extension · Marking Drill · Point Drill · +2 | 6 | 2023 |
| Materialise NV | Belgium | Maker | CMF Plastic Models · CMF Titanium Guides · Materialise Mimics Enlight CMF · Materialise Personalized Guides and Models for Craniomaxillofacial Surgery · +4 | 5 | 2026 |
| WARANTEC Co., Ltd. | South Korea | Maker | AD-32 · AD-38 · BP-45 · BP-55 · +195 | 4 | 2023 |
| MedCAD | United States | Maker | AccuPlan System 3DTi | 4 | 2023 |
| SNUCONE Co., LTD. | South Korea | Maker | BONE FLATTENER · BONE TRIMMER · COUNTER SINK · GUIDE COUNTER SINK PROFILER · +13 | 2 | 2023 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Handpiece, Metal Quick Disconnect | 2 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Bondent® Drills · Kodex® Drills · Max® Drills · ParaPost® Drills · +8 | 45 | 2022 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| DIO Corporation | South Korea | Maker | Connector Extension · Cortical Drill · Deep Bone Flattening Drill · DIO Bone Expander Kit · +83 | 14 | 2023 |
| A.B. Dental Devices , Ltd. | Israel | Maker | AB Guided Surgical Box · AB Guided Surgical Kit · ABGuide Bone Mill D5.5mm Conical Platform · ABGuide Bone Mill D5.5mm Internal Hex · +243 | 4 | 2026 |
| BIO CONCEPT Co., Ltd | China | Maker | Anchor Drill · AutoBone Collector · Bone Profiler · BV Guide Drill · +17 | 3 | 2022 |
| 3D Systems, Inc. | United States | Maker | Jaw in a Day · VSP Distraction · VSP Orthognathics · VSP Reconstruction · +2 | 3 | 2026 |
| bredent GmbH & Co. KG | Germany | Maker | — | 3 | 2024 |
| Surgikor, LLC | United States | Maker | Counter Sink Drill · Lance Drill 1.4 mm · Pilot Drill dia 2 mm · Straight Drill with Stopper without Irrigation · +1 | 2 | 2024 |
| Uniqa Dental, Ltd. | Israel | Maker | Conical drills with external irrigation · Countersink, one size · Countersink, two sizes · Drill extender · +13 | 2 | 2026 |
| Sewon Medix, Inc. | South Korea | Maker | BONE TRIMMER (SBT50) · Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper) · Drill & Drill Accessories (Sidecut Drill, Bone Profiler, Trephine Drill) · EXPANDER DRILL (SEP162808, SEP162810, SEP162811, SEP223608, SEP223610, SEP223611) · +40 | 2 | 2023 |
| Cybermed Inc. | South Korea | Maker | ABT. Profiler · Anchor Drill · Bone Flatter · Bone Profiler · +45 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Drills for dental post · Drills for fibre post · Gate Drills · Peeso Reamers | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Bone Bur · Bone chisel · Bone Drill · Bone Extractor · +26 | 1 | 2026 |
| Overfibers S.R.L. | Italy | Maker | Conical Drill # Large · Conical Drill # Medium · Conical Drill # Small · Cylindrical Drill # 0,8 · +20 | 1 | 2025 |
| DIMPLO Ltd. | South Korea | Maker | Anchor Drill · Bone Flat Drill · Core Drill · Cortical Drill · +14 | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · Fliex · NIC · ROOT.X · +2 | 1 | 2025 |
| Shenzhen Dazhou Medical Technology Co., Ltd. | China | Maker | Step Drill | 1 | 2025 |
| 3D LifePrints UK | United Kingdom | Maker | EmbedMed | 1 | 2022 |
| Bicon, LLC | United States | Maker | Pilot Drill | 18 | 2015 |
| Bonart Co., Ltd. | Taiwan | Maker | ARTEOTOMY Oral Surgery System and Accessories (Model No. BIS) · ARTEOTOMY-OM1/OP1 ULT.SURGERY SYS. | 14 | 2017 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | STEEL DRILLS | 11 | 2021 |
| Biomet Microfixation | United States | Maker | Pre-bent Plates with Virtual Surgical Planning · Virtual Surgical Planning · VSP | 8 | 2021 |
| ITENA Clinical | France | Maker | DRILL, DENTAL, INTRAORAL | 8 | 2017 |
| SYNTHES (USA) Products LLC | United States | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SY · Synthes 90 Degree Screwdriver · Dental Bone Cutting Instruments | 7 | 2020 |
| SWEDEN & MARTINA S.p.A. | Italy | Maker | DIAMOND BUR · PREPARATION DRILLS KIT FOR B.O.P.T. · PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. | 6 | 2019 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SY · Synthes 90 Degree Screwdriver · Dental Bone Cutting Instruments | 5 | 2013 |
| Electro Medical Systems SA | United States | Maker | Piezon Master Surgery | 5 | 2002 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| DMETEC Co., LTD | South Korea | Maker | ULTRASONIC SURGERY · ULTRASONIC SURGERY MACHINE | 5 | 2017 |
| Rhein'83 Srl | Italy | Maker | A01MOG MOOSER BUR FOR PIVOT h7-9-10 · BROKEN SCREW EXTRACTOR KIT · 680ANP ESTRATTORE IMP. ADIN UNP ø 2,75 · 680CAM5 ESTRATTORE IMP. CAMLOG ø 5 · +5 | 4 | 2018 |
| Cortex Dental Implants Industries Ltd. | Israel | Maker | CD-0206 · CD-0208 · CD-0210 CD-0211 CD-0213 CD-0216 CD-2806 CD-2808 CD-2810 CD-2811 CD-2813 CD-2816 · CD-1001 CD-5003 CD-5010 CD-5020 CD-5025 CD-5030 CD-5040 CD-5045 CD-5050 CD-5060 · +28 | 4 | 2019 |
| Medimecca Co., Ltd. | South Korea | Maker | Cortical Drill · DG00 · DSR (Disk-up Sinus Reamer) · Guide (Point) Drill · +7 | 4 | 2020 |
| Oco Biomedical | United States | Maker | DENTAL INTRAORAL DRILL | 4 | 2013 |
| Nouvag AG | Switzerland | Maker | Handpieces ENT · HighSurg 30 · MD 11 · MD 30 | 4 | 2008 |
| Bioloren S.R.L. | Italy | Maker | Bioloren drill | 3 | 2018 |
| S.G.S. International Ltd | Hungary | Maker | Conical Drill · Conical Drill with Stopper · Conical stopper drill · Drill Extender · +13 | 2 | 2019 |
| Ritter Implants GmbH and Co. KG | United States | Maker | CD-2.5 · CD-2.8 · CD-3 · CD-3.3 · +91 | 2 | 2019 |
| Alliance Global Technology Co., Ltd. | Taiwan | Maker | DRILL, DENTAL, INTRAORAL | 2 | 2016 |
| Zuga Medical, Inc. | United States | Maker | Dental Drills for Zuga Dental Implant Systems | 2 | 2018 |
| Dpm USA Corp. | United States | Maker | Switch E | 2 | 2009 |
| ConMed CORP. | United States | Maker | PowerPro Pneumatic | 2 | 2006 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| TAG Medical products corporation LTD | United States | Maker | Conical Drill for implant ø3.75mm · Conical Drill for implant ø4.20mm · Conical Drill for implant ø5mm · Conical Drill for implant ø6mm · +23 | 1 | 2015 |
| DENTIN Implants Technologies Ltd. | Israel | Maker | Conical Drill · Countersink Surgical Drill · Drill / CHEAT Drill · Drill set · +2 | 1 | 2012 |
| Directa AB | Sweden | Maker | Big Apical Files · Paste Filler · S1 Plus · S5 Rotary Files Starter Pack · +2 | 1 | 2015 |
| Nova Implants | Israel | Maker | Dental Drill | 1 | 2015 |
| Iq Implants , Ltd. | Israel | Maker | Conical Drills with External Irrigation · Conical Drills with Internal Irrigation · Countersink · Cylindrical Drills Internal Irrigated · +12 | 1 | 2013 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET INTRAORAL DENTAL DRILL · KOMET BONE CUTTING INSTRUMENT AND ACCESSORY | 1 | 2007 |
| Arnold Tuber Industries | United States | Maker | DENTAL DRILLS · DENTAL SCREWS | 1 | 2009 |
| Ronvig Dental Mfg. A/S | Denmark | Maker | CTT CERAMIC TISSUE TRIMMER | 1 | 2006 |
| Osseo Scientific, LLC | United States | Maker | Low Temp Dental Drill | 1 | 2007 |
| Silfradent srl | Italy | Maker | Surgybone | 1 | 2009 |
| ImmersiveTouch | United States | Maker | ImmersiveView Surgical Plan | 1 | 2020 |
| Osung Mnd Co Ltd | South Korea | Maker | BEPDP13 · BSWDR1 · BSWDR1.3 · BSWDR1.6 · +4 | — | — |
| Noga Medical Products Ltd. | Israel | Maker | — | — | — |
| Intai Technology Corp. Implants Business Unit | Taiwan | Maker | CF 3.5 x 10 Final Implant Drill · CF 3.5 x 11.5 Final Implant Drill · CF 3.5 x 13 Final Implant Drill · CF 3.5 x 15 Final Implant Drill · +83 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Tomas-drill | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental Drills | — | — |
| TruAbutment Korea Co Ltd | South Korea | Maker | Anchor Drill · Bone Profiler · Final Drill · Flat Drill · +21 | — | — |
| D.S.P. Industrial EIRELI EPP | Brazil | Maker | ANGLED HE COUNTERSINK DRILL · ANGLED HE DRILLS · ANGLED HE INITIAL DRILL · CONICAL BONE DENSIFIERS · +24 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Drills for Ouro Post · Drills for Screw Post · Drills for Tapered Screw Post · Endo Enlarger · +4 | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Drill | — | — |
| PointImplant Co Ltd | South Korea | Maker | Bone Profile Drill · Cortical Drill · Final Drill · Fixture Tap Drill · +5 | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | FKG · GATES · GATES GLIDDEN · PEESO · +2 | — | — |
| ACH Medical Co., Ltd. | South Korea | Maker | Cortical drill · Diamond Lindermann drill · Pilot drill · Sidecut drill · +3 | — | — |
| Lacigrus International | Pakistan | Maker | DRILL, DENTAL, INTRAORAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | dental drills | — | — |
| Dentatus AB | Sweden | Maker | RSA · RSB · RSC · RSG · +8 | — | — |
| Mani, Inc. (Head Office) | Japan | Maker | Gates Drills · MANI GATES DRILLS · MANI PEESO REAMERS · Peeso Reamers | — | — |
| NTI Kahla GmbH Rotary Dental Instruments | Germany | Maker | NTI · NTI Endo Root facers · NTI Gates Glidden drills · NTI Peeso reamers · +1 | — | — |
| Kaiser Precision Co. | South Korea | Maker | Drill Extension · Lifting Drill · Lindemann Drill · Point Drill · +15 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Unique Instruments Inc. | United States | Maker | cross cut fissure bur · DENTAL BONE CUTTING INSTRUMENTS · Genesis Implant System · TAPERED DRILL FOR ? 9 MAX · +28 | — | — |
| Micro Precision Swiss, LLC | United States | Maker | Dense Bone Drill · Drill Tapered · Guided Counterbore · Guided Dense Bone Drill Tapered · +3 | — | — |
| Surgicrafts | Pakistan | Maker | DZA / DRILL, DENTAL, INTRAORAL | — | — |
| Garana Industries (PVT) Ltd | Pakistan | Maker | Trephine Drills | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Speed Handpiece | — | — |
| Produits Dentaires SA | Switzerland | Maker | Drill-A-Post | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | iTesla Dental Implant System | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Endodontic Enlarger Drills/ Gates Drills / Dental Post Drills / Peeso Reamers / Fiber Post Drills | — | — |
| Jabil Inc. | United States | Maker | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM · Synthes 90 Degree Screwdriver | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Drill, Dental, Intraoral | — | — |
| Dentech Corp. | Japan | Maker | Dentech Corporation | — | — |
| Digital Dental Depot Limited | Hong Kong SAR China | Maker | DRILL, DENTAL, INTRAORAL · DZA / DRILL, DENTAL, INTRAORAL | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | Speed Handpiece | — | — |
| DUNAMIS DENTAL Co., Ltd. | South Korea | Maker | Karam-AM · Karam-ANG · Karam-Delix · Karam-Lab · +15 | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | DENTAL IMPLANT DRILL | — | — |
| Hospimed Mfg | Pakistan | Maker | Drill, Dental, Intraoral | — | — |
| Hans Korea | South Korea | Maker | Hans Korea | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT - 1DERFUL : GATES DRILL, PEESO REAMER, PASTE FILLER. | — | — |
| Win Wings Corp. | Pakistan | Maker | DRILL, DENTAL, INTRAORAL | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | — | — | — |
| Edenta Etablissement | Liechtenstein | Maker | ACHROMAT · NTI | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Frueh Verpackungstechnik AG | Switzerland | Maker | Electric Pen Drive System | — | — |
| Straits Orthopaedics (Mfg) Sdn Bhd | Malaysia | Maker | 5100 215 306 BEARING SPACER · 5100-010-028 BEARING PRELOAD RING · 5100-010-239 BEARING SLEEVE · 5110-901-912 NOZZLE · +4 | — | — |
| United Dental Changzhou | China | Maker | Rotary files/Root canal files, Hand use files/Manual files, Sterile Root Canal Files | — | — |
| Creative Endodontic Technology LLC | United States | Maker | CET Gate Drills | — | — |
| Dhef Inc. | Taiwan | Maker | DRILL · INTRAORAL | — | — |
| Digital Dental Depot | China | Maker | intraoral | — | — |
| Funing Meitedental Factory | China | Maker | Dental drills | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Shanghai Toboom Dental Techology CO., LTD. | China | Maker | DRILL, DENTAL, INTRAORAL | — | — |
| Diaswiss, S. A. | Switzerland | Maker | DRILL, DENTAL, INTRAORAL | — | — |
| E Hahnenkratt GmbH | Germany | Maker | HAHNENKRATT DRILLS | — | — |
| Precision Edge Surgical Products Company | United States | Maker | COUNTERSINK W/CENTERING PINS FOR 2.4MM SCREWS/HEX COUPLING · COUNTERSINK W/CENTERING PINS FOR 2MM SCREWS/HEX COUPLING | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS DRILL, DENTAL, INTRAORAL | — | — |
| Symmetry Medical Polyvac SAS | France | Maker | PACK PIEZOTOME 2 | — | — |
| puracon GmbH | Germany | Maker | — | — | — |
| Baechler Feintech AG | Switzerland | Maker | Shaft f/Screwdriver 90° | — | — |
| Josef Ganter Feinmechanik GmbH | Germany | Maker | Drill, Dental, Intraoral | — | — |
| Sphinx Tools Ltd | Switzerland | Maker | SYNTHES · Fairfax | — | — |
| DOIFF Co., Ltd. | South Korea | Maker | DSSK01, LCD1525, LCD1828, LCD2228, LCD2535, LCD2838, LCD3238, LCD3545, LCD3848, LCD4248, LCD4555, LCD4858, LCD5258 · Sinus Simple Kit | — | — |
| Dti Implant Systems | Türkiye | Maker | DTI | — | — |
| Jiangyin Jintaike Biotech Co., Ltd. | China | Maker | DRILL, DENTAL, INTRAORAL | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | Burs 11-018-5 | — | — |
| Precera Medical Inc | United States | Maker | Surgical Drill System | — | — |
| Fairfax MEDICAL PRODUCTS Ltd | United Kingdom | Maker | Stabilok drill | — | — |
| Sentronic International Corp. | Taiwan | Maker | "G-Be-Bite" Intraoral dental drill | — | — |
| The Anspach Effort Inc | United States | Maker | Electric Pen Drive · Synthes | — | — |
| iLumi Sciences inc | United States | Maker | Dental Fiber Post Drill | — | — |
| Bio Composants Medicaux (BCM) | France | Maker | — | — | — |
| COHO Advanced Materials Tech. Co., Ltd. | Taiwan | Maker | — | — | — |
| My Implant Business GmbH | Germany | Maker | Easy Bone Collector | — | — |
| Veridiam, LLC. | United States | Maker | Universal Drill Extender | — | — |
| Zonefly Medical Devices Co., Ltd. | China | Maker | — | — | — |
| Abnox AG | Switzerland | Maker | — | — | — |
| Acumed LLC | United States | Maker | — | — | — |
| Avalign Instruments & Implants | United States | Maker | — | — | — |
| Digital Arches Inc. | United States | Maker | — | — | — |
| Frank Dental GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Hipp Medical AG | Germany | Maker | — | — | — |
| Khoury Dent Ltd Via Kasko K.N Ltd | Israel | Maker | — | — | — |
| KLS Martin Manufacturing, LLC | United States | Maker | — | — | — |
| MedCare Solutions GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Dentis Co., Ltd. | South Korea | Foreign exporter | Silfradent SRL | 37 | 2026 |
| Voco GmbH | Germany | Foreign exporter | Rebilda Post Drill | 117 | 2026 |
| Hiossen Inc. | United States | Manufacturer | SM3 | 26 | 2026 |
| Sybron Dental Specialties | United States | Contract manufacturer | Gates Glidden Drills | 203 | 2026 |
| Premier Dental Products Company | United States | Contract manufacturer | INTEGRA POST DRILLS | 28 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Johnson Promident Reamers, Post Drills | 23 | 2025 |
| Park Dental Research Corp | United States | Contract manufacturer | NR Piezo | 8 | 2026 |
| Dentscare Ltda | Brazil | Manufacturer | Whitepost DC Drill · Whitepost DC-E Drill · Whitepost System DC Drill · Whitepost System DC Fit · +1 | 10 | 2024 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | Countersink Drill · Primary Reamer, Secondary Drill, Gates Glidden Drill, Peeso Reamer, Pleezer Reamer | 15 | 2023 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Classic Reamer | 4 | 2004 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | Dental handpiece | 3 | 2007 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Integra · Miltex · Padgett · Tri-R Post | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Contract manufacturer | Pilot Drill | 2 | 2008 |
| Suncoast Dental Corp. | United States | Repacker / relabeler | Pilot Drill 1, 1.5, 1.8, 2 · Tapered Drill 3.5x11,14,17,20 · Tapered Drill 4.5x11,14,17,20 · Tapered Drill 4x11,14,17,20 · +4 | 2 | 1981 |
| Abrasive Technology, Inc. | United States | Manufacturer | CARBOPOST, SNOWPOST, SNOWLIGHT · DRILL · INTRAORAL | 1 | 1990 |
| Engineered Endodontics | United States | Repacker / relabeler | Filpin Drill | 1 | 2019 |
| Sicat GmbH & Co. KG | Germany | Foreign exporter | Endo Dental Bur | 1 | 2016 |
| alfa gate - mazen ltd. | Israel | Foreign exporter | Alfa Gate | 1 | 2019 |
| Sotera Health LLC | United States | Contract manufacturer | ProGlider · ProTaper Gold · 0300.317S · Propel Device, RT open / Closed · +1 | — | — |
| Sweden & Martina INC | United States | Lister | DIAMOND BUR · PREPARATION DRILLS KIT FOR B.O.P.T. · PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. · CONTRAANGLE FOR SURGERY 1:1 · +1 | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Peeso Reamer 32mm, #1 - #6, Stainless Steel, Assorted, 6/Pk · Valdent USA Peeso Reamer 32mm, #1, Stainless Steel, 6/Pk · Valdent USA Peeso Reamer 32mm, #2, Stainless Steel, 6/Pk · Valdent USA Peeso Reamer 32mm, #3, Stainless Steel, 6/Pk · +3 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL DRILL · FIBER POST DRILL · INTRAL ORAL TIP | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO IMPORT & EXPORT LIMITED | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Drill | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Gates Glidden Drills (Engine-Driven Reamers) · Dental Electric Motor / Dental Implantation System | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Dental Drill · Patterson Gates Glidden Grills | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | dental | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | Sonic surgical instrument and accessories/attachments · SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM · SYNTHES 90 DEGREE SCREWDRIVER · Dental Bone Cutting Instruments | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | AI SURGERY | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Gate Drills · Peeso Reamers | — | — |
| GoldenDent | United States | Repacker / relabeler | Piezo Implant Motor | — | — |
| TBS Dental | United States | Repacker / relabeler | Dental Drill · Universal Shapers | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | DRILL · INTRAORAL | — | — |
| Aragogamma, S.L. | Spain | Contract sterilizer | Dental Drills for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant Systems | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO · Nakanishi Inc. | — | — |
| EMS Electro Medical Systems SA | Switzerland | Foreign exporter | PIEZON MASTER SURGERY | — | — |
| Henry Schein MSO, LLC | United States | Repacker / relabeler | NSK | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | Foot Control · Instrument changer · Instrument Set BONE · Instrument Set ENDO · +3 | — | — |
| Piezosurgery, Inc DBA Mectron North America | United States | Lister | MT-Bone · Piezosurgery // · Piezosurgery 3 · Piezosurgery Flex · +4 | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Gates Drills | — | — |
| Sanicure BV | Netherlands | Foreign exporter | HANDPIECE, ROTARY BONE CUTTING | — | — |
| Zapalign LLC | United States | Repacker / relabeler | HANDPIECE, ROTARY BONE CUTTING | — | — |
| DePuy Synthes, Inc. | United States | Manufacturer | Synthes 90 Degree Screwdriver · Dental Bone Cutting Instruments | — | — |
| Enova Illumination Inc. | United States | Lister | Piezo Surgery | — | — |
| Reliable Dental Studio, Inc. | United States | Remanufacturer | Grinding Attachment · Grinding Tool · Intraoral · You Fit Dental Drill · +1 | — | — |
| CBR Enterprise Limited | Hong Kong SAR China | Foreign exporter | DRILL, DENTAL, INTRAORAL | — | — |
| Rose GmbH fuer Medizintechnik | Germany | Contract sterilizer | — | — | — |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Türkiye | Foreign exporter | STRYKER TOTAL PERFORMANCE (TPS) SYSTEM · BURR | — | — |
| Nouvatec LLC | United States | Repacker / relabeler | Nouvag AG | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Steritech, Inc. | United States | Contract sterilizer | D186182 | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Universal Sapers | United States | Repacker / relabeler | Universal Shaper Dental Drills | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| SOMI medical GmbH | Germany | Contract sterilizer | — | — | — |
| Veenak International Limited | United Kingdom | Foreign exporter | — | — | — |
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 surgical drills 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA | 1 | 872.4130 | 134 | 13 |
| Powered Bone DrillDZI | 2 | 872.4120 | 34 | 50 |
| Manual Wire Driver and Bone DrillDZJ | 2 | 872.4120 | 25 | 33 |
| Rotary Bone Cutting HandpieceKMW | 2 | 872.4120 | 5 | 9 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Oct 2026 | K260913 | CMF Titanium Splints | Materialise NV | DZJ Manual Wire Driver and Bone Drill |
| 31 Jul 2026 | K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | DZI Powered Bone Drill |
| 18 Jun 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | DZI Powered Bone Drill |
| 3 Jun 2026 | K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 23 Dec 2025 | K254163 | VarioSurg 4 | Nakanishi, Inc. | DZI Powered Bone Drill |
| 21 Feb 2025 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | DZJ Manual Wire Driver and Bone Drill |
| 11 Dec 2024 | K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 19 Aug 2024 | K242432 | MT-Bone | Mectron S.P.A. | DZI Powered Bone Drill |
| 18 Jul 2024 | K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong JINME Medical Technology Co., Ltd. | DZI Powered Bone Drill |
| 2 Oct 2023 | K231520 | tmCMF Solution | Techmah Cmf | DZJ Manual Wire Driver and Bone Drill |
| 16 Aug 2023 | K231087 | Guided Surgery Kit | Implant Direct | DZI Powered Bone Drill |
| 23 Jun 2023 | K230276 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 7 Mar 2023 | K223024 | MedCAD AccuPlan System | MedCAD | DZJ Manual Wire Driver and Bone Drill |
| 30 Sep 2022 | K220366 | EmbedMed | 3D LifePrints UK | DZJ Manual Wire Driver and Bone Drill |
| 11 Aug 2022 | K220648 | OMF ASP System | Vha Dean | DZJ Manual Wire Driver and Bone Drill |
| 11 Feb 2022 | K212570 | OsteoPlan System | Osteomed, LLC | DZJ Manual Wire Driver and Bone Drill |
| 19 Aug 2021 | K211584 | Oral Surgery Contra | Nakanishi, Inc. | KMW Rotary Bone Cutting Handpiece |
| 28 Jun 2021 | K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 21 Jun 2021 | K193301 | coDiagnostiX | Institut Straumann AG | DZJ Manual Wire Driver and Bone Drill |
| 26 Apr 2021 | K210347 | VSP System | 3D Systems, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 4 Nov 2020 | K193499 | DigiGuide System | Protomed, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 29 Oct 2020 | K192282 | MedCAD® AccuPlan® System | MedCAD | DZJ Manual Wire Driver and Bone Drill |
| 13 Jul 2020 | K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | DZI Powered Bone Drill |
| 30 Jun 2020 | K200265 | Surgical Drills | Implant Direct | DZI Powered Bone Drill |
| 9 Jun 2020 | K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip | Bennett Jacoby, Dds, Ms, Inc. | DZI Powered Bone Drill |
| 9 Jun 2020 | K181813 | ImmersiveView Surgical Plan (IVSP®) | ImmersiveTouch | DZJ Manual Wire Driver and Bone Drill |
| 26 Feb 2020 | K192192 | VSP System | 3D Systems, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 11 Mar 2019 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS Martin SE & Co. KG | DZJ Manual Wire Driver and Bone Drill |
| 13 Sep 2018 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS Martin SE & Co. KG | DZJ Manual Wire Driver and Bone Drill |
| 3 May 2018 | K172137 | PIEZOTOME CUBE | Satelec - Acteon Group | DZI Powered Bone Drill |
| 13 Apr 2018 | K171326 | Piezosurgery White | Mectron S.P.A. | DZI Powered Bone Drill |
| 17 Jan 2018 | K172164 | PROPEL Device | Propel Orthodontics, LLC | DZJ Manual Wire Driver and Bone Drill |
| 12 Jan 2018 | K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | DZI Powered Bone Drill |
| 21 Nov 2017 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | KMW Rotary Bone Cutting Handpiece |
| 4 Apr 2017 | K162544 | OsteoMed PINNACLE Driver | Osteomed, LLC | KMW Rotary Bone Cutting Handpiece |
| 15 Aug 2016 | K152125 | Oral Surgery System and Accessories | Bonart Co., Ltd. | DZI Powered Bone Drill |
| 18 Sep 2015 | K150392 | PROPEL device | Propel Orthodontics, LLC | DZJ Manual Wire Driver and Bone Drill |
| 4 Sep 2015 | K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | DZI Powered Bone Drill |
| 1 Sep 2015 | K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | DZI Powered Bone Drill |
| 23 Jun 2015 | K150796 | Dental Bone Cutting Instruments | SYNTHES (USA) Products LLC | DZJ Manual Wire Driver and Bone Drill |