Surgical devices · 21 CFR 872 Subpart E
Intraoral Dental Drill
FDA device type “Drill, Dental, Intraoral”.
- Companies listing it
- 176134 makers
- Brands and models
- 2,007
- 510(k) clearances
- 130 in five years
- FDA name
- Drill, Dental, Intraoral
510(k) clearances per year, 1976–2026
Companies that list DZA
176 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | EUROPOST · EXCELPOST | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Drills · GATES · LARGO | 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 · +17 | 30 | 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 |
| 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 |
| Ossvis Co., Ltd. | South Korea | Maker | Bone Profile Drill · Cortical Drill · Cortical Drill S2 · Crestal Drill · +25 | 7 | 2024 |
| Chengdu Besmile Medical Technology Co., Ltd. | China | Maker | Drill | 5 | 2026 |
| 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 · +34 | 7 | 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 |
| 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 |
| WARANTEC Co., Ltd. | South Korea | Maker | AD-32 · AD-38 · BP-45 · BP-55 · +195 | 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 |
| 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 |
| 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 |
| Bicon, LLC | United States | Maker | Pilot Drill | 18 | 2015 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | STEEL DRILLS | 11 | 2021 |
| ITENA Clinical | France | Maker | DRILL, DENTAL, INTRAORAL | 8 | 2017 |
| 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 |
| 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 |
| 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 |
| 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 | 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 |
| 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 | Genesis Implant System · TAPERED DRILL FOR ? 9 MAX | — | — |
| 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 | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Endodontic Enlarger Drills/ Gates Drills / Dental Post Drills / Peeso Reamers / Fiber Post Drills | — | — |
| 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 | — | — | — |
| 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 | — | — |
| Jota AG | Switzerland | Maker | JOTA | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS DRILL, DENTAL, INTRAORAL | — | — |
| Symmetry Medical Polyvac SAS | France | Maker | — | — | — |
| puracon GmbH | Germany | Maker | — | — | — |
| Josef Ganter Feinmechanik GmbH | Germany | Maker | Drill, Dental, Intraoral | — | — |
| Sphinx Tools Ltd | Switzerland | Maker | 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 | — | — |
| 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 | — | — | — |
| Digital Arches Inc. | United States | Maker | — | — | — |
| Frank Dental GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Khoury Dent Ltd Via Kasko K.N Ltd | Israel | Maker | — | — | — |
| MedCare Solutions GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Voco GmbH | Germany | Foreign exporter | Rebilda Post Drill | 117 | 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 |
| 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 | — | — |
| 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. | — | — |
| 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) | — | — |
| 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 | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | Gate Drills · Peeso Reamers | — | — |
| 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 | — | — |
| E/T Endodontic Technologies, Ltd. | Canada | Foreign exporter | MANI Gates Drills | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| 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 | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Jun 1999 | K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | W&H Dentalwerk Buermoos GmbH |
| 25 Sep 1996 | K962979 | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. |
| 16 Jan 1996 | K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Dentsply Sirona, Inc. |
| 27 Jul 1993 | K914724 | ADA SHANK EXTENSION | Implant Corp. of America |
| 25 Jul 1991 | K905418 | GATES GLIDDEN DRILLS | The Hygenic Company, LLC |
| 25 Apr 1990 | K901097 | FILLOCK REAMER | Ivoclar North America, Inc. |
| 19 Jan 1990 | K896149 | ANEST-EZE DENTAL DRILL RA#2 | Signature One Products, Inc. |
| 22 Dec 1988 | K884187 | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. |
| 16 Jun 1981 | K811113 | RIESS-LUHR | Allomedic |
| 20 Aug 1980 | K801888 | HANDPIECE, DENTAL | Aesculap Instruments Corp. |
| 20 Aug 1980 | K801887 | DRILL, DENTAL | Aesculap Instruments Corp. |
| 23 Dec 1976 | K761275 | AIROTOS LF HANDPIECE | Dentsply Intl., Inc. |
| 19 Nov 1976 | K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. |
Official records: FDA product classification for DZA · 21 CFR 872.4130.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026