Surgical devices · 21 CFR 872 Subpart E
Dental Instrument Handle
FDA device type “Handle, Instrument, Dental”.
- Companies listing it
- 251204 makers
- Brands and models
- 666
- 510(k) clearances
- 80 in five years
- FDA name
- Handle, Instrument, Dental
510(k) clearances per year, 1976–2026
Companies that list EJB
251 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | — | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Dental Tools | 148 | 2026 |
| GC America Inc. | United States | Maker | Applicator Holder · APPLIER III · Applier IV · GC Capsule Applier V · +8 | 137 | 2026 |
| Ossvis Co., Ltd. | South Korea | Maker | Handle for tips | 7 | 2024 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Implant Protesis Dental 2004, S.L. | Spain | Maker | Clinical RA shank handle · Clinical RA Shank Handle Kit 18 mm · Clinical RA Shank Handle Kit 25 mm · Laboratory RA shank handle · +1 | 6 | 2026 |
| B.t.i. Biotechnology | Spain | Maker | — | 14 | 2024 |
| Dent4You AG | Switzerland | Maker | Dental Dam Punch | 5 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Manual Handle | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | PREMIER INSTRUMENT HANDLE | 28 | 2026 |
| Young Innovations Inc | United States | Maker | AEI Mirror Handles · AEI Quik Tip Handles · Ivoclar Optrasticks · Microstix | 23 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | — | 16 | 2026 |
| Shinhung Mst Co., Ltd. | South Korea | Maker | ADH10 · ASL · ASS · BCD14 · +198 | 7 | 2023 |
| Keystone Dental Inc. | United States | Maker | Genesis Implant System · Prima Dental Implant System · RENOVA Dental Implant System · RESTORE Dental Implant System · +2 | 7 | 2024 |
| Centrix, Inc. | United States | Maker | StatStix | 44 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | — | 20 | 2026 |
| InnoBioSurg Co.,Ltd | South Korea | Maker | Open Wrench · Torque Wrench | 15 | 2022 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Premium Plus (Dongguan) Limited | China | Maker | Hand instruments · Plastic wedges | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | DENTAL DAM PUNCH | 45 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | C-MOR · Wrench | 15 | 2023 |
| Neoss AB | Sweden | Maker | Adjustment handle | 10 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | Instrument Handle · Interproximal Stripper and Blade Refill | 8 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | MHD-SMS · MHD-Y · MHD12 · MHD15 · +8 | 5 | 2023 |
| A.B. Dental Devices , Ltd. | Israel | Maker | Driver for installing I-On implant through AB Guide · Hand Dynamic Driver L15mm · Implant mount for guided kit L9mm CP · Long Drill D2.3 L40mm · +4 | 4 | 2026 |
| Garrison Dental Solutions LLC | United States | Maker | A+ Wedge · ClearView · Composi-Tight® · G Wedge · +3 | 3 | 2024 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Infinity Endo Obturation Gun · Infinity Endo Obturation Pen · Obturation pen, Obturation Pen, Obturation Gun | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Bone Graft Bowl · Bone Scraper (Angled) · Bone Scraper (Straight) · Bone Tack Gun · +16 | 1 | 2026 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | Gutta Percha Cutting Pen | 1 | 2023 |
| Thommen Medical AG | Switzerland | Maker | — | 26 | 2017 |
| Aseptico, Inc. | United States | Maker | AEU-45 FAMILY | 17 | 2015 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Biomet Microfixation | United States | Maker | Handle | 8 | 2021 |
| ITENA Clinical | France | Maker | HANDLE, INSTRUMENT, DENTAL | 8 | 2017 |
| Micerium S.P.A. | Italy | Maker | ENA · ENA MATRIX Sectional Matrix System · MAS Gingival protection · MAS Surgical guide · +5 | 6 | 2011 |
| Basic Dental Implant Systems, Inc. | United States | Maker | Double End Implant Driver | 6 | 2008 |
| Osteogenics Biomedical, Inc. | United States | Maker | Pro-fix Driver Handle | 5 | 2021 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Dentmas · PREMIUM HAND INSTRUMENTS | 3 | 2017 |
| OT medical GmbH | Germany | Maker | OT-F³ Osteotome Handle, bended · OT-F³ Osteotome Handle, straight · OT-F³ Tip wrench | 3 | 2016 |
| Integra LifeSciences Corporation | United States | Maker | GripLite · Jarit · Miltex · RMH Integrator · +2 | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Stomaform-handel, handle, scalpel-handle, mirror and probe handle, scalpel blade holder, mirror handle, special handle | 2 | 2008 |
| Lascod Spa | Italy | Maker | ZEFFIRO | 2 | 2020 |
| DB Orthodontics Limited | United Kingdom | Maker | IXION | 2 | 2010 |
| Alliance Global Technology Co., Ltd. | Taiwan | Maker | HANDLE, INSTRUMENT, DENTAL | 2 | 2016 |
| B&L Biotech Co., Ltd. | South Korea | Maker | JETip Instrument · JIHB · JIHG · JIHS · +5 | 1 | 2006 |
| Directa AB | Sweden | Maker | Ceramir Applicator · COLOUR CODE RINGS · FenderPrep · FenderWedge · +4 | 1 | 2015 |
| Ronvig Dental Mfg. A/S | Denmark | Maker | COMPO-JECT COMPOSITE APPLICATOR | 1 | 2006 |
| Medical Systems and Devices International Ltd. | Israel | Maker | MSDI Dental Tools | 1 | 2020 |
| Forward Science LLC | United States | Maker | FS Dispenser - Stainless | 1 | 2013 |
| Osung Mnd Co Ltd | South Korea | Maker | MHC · MHS · SH2S · SHC · +6 | — | — |
| TOR VM Ltd. | Russia | Maker | Cat.#1.100 Handle · Cat.#1.100T Handle, titanium · Cat.#1.107 Handle · Cat.#1.109 Handle | — | — |
| ErgoDenta ApS | Denmark | Maker | Ergo LX - ErgoTip handle, Single-end, Aqua light · Ergo LX - ErgoTip handle, Single-end, Black · Ergo LX - ErgoTip handle, Single-end, Grey · Ergo LX - ErgoTip handle, Single-end, Lemon Green · +22 | — | — |
| Zain's Medical Image | Pakistan | Maker | Larygneal Mirror Handle · Mirror Handle | — | — |
| Densol International (Private) Limited | Pakistan | Maker | Mirror Handle Hexagonal Hollow 10mm · Mirror Handle Round Hollow 10mm · Mirror Handle Round Hollow 6mm · Mirror Handle Solid Hexagonal 6mm | — | — |
| Metro Medical | Pakistan | Maker | Elevator Handle A (Large) Stainless Steel · Elevator Handle B (Medium) Stainless Steel · Tube Handle D/E 0.5mm, 1.15mm Tube Handle D/E 0.5mm, 2.8mm Tube Handle S/E 0.5mm, 1.15mm | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Mirror handle | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Molar band seater · Separating strip holder | — | — |
| 株式会社ＹＤＭ | Japan | Maker | P-A Handle · P-B Handle · P-C Handle · P-F Handle | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental instrument handle | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DoctorNice | — | — |
| Prodont-Holliger | France | Maker | MIRROR HANDLE reference 2120SI · MZP214IP - MCHE ARTICULE POUR MIROIRS I.P · 2100D - MIRROR HANDLE DESIGN SIMPL STEM · 2120DIP - MCHE MIROIR INOX CSS DESIG I.P · +2 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Obturation pen, Obturation Pen, Obturation Gun | — | — |
| Bashir Jamil & Bros. (Pvt.), Ltd. | Pakistan | Maker | Mirror Handle, Octagonal, Cone Socket, with Millimeter Rule | — | — |
| TDV Dental Ltda | Brazil | Maker | ESTHETIC PLUS · SeptoCompo Shape | — | — |
| Technimen Skillers | Pakistan | Maker | FILES · INSTRUMENTS · VARIOUS TYPES OF HANDLES | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Featherweight · Z-Soft · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Dental Handle | — | — |
| MC Bio s.r.l. | Italy | Maker | Advanced Set · Aluminum Tack Placement Instrument · Back applicator · Back applicator tip · +28 | — | — |
| Medcave Private Limited | Pakistan | Maker | Handle Instrument dental | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT MIRROR HANDLE | — | — |
| Panorama International | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Accompany Surgical | Pakistan | Maker | HANDLE | — | — |
| Lacigrus International | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | HANDLE INSTRUMENT DENTAL | — | — |
| GoldenDent | United States | Maker | WagoTrix Wedge | — | — |
| Aesculap AG | Germany | Maker | DENTAL INSTRUMENT HANDLE | — | — |
| Dentatus AB | Sweden | Maker | Profin-By-Hand | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | BROACH HOLDERS · HANDLES FOR MIRRORS · HANDLES FOR PROBES | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Dental Instrument | — | — |
| Denta Craft Instruments | Pakistan | Maker | HANDLE | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Aditek do Brasil SA | Brazil | Maker | Bite Turbo | — | — |
| Hilbro Instruments (Pvt) Ltd | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL · HILBRO INSTRUMENTS DE | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Mirror Handle | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Suzhou Ramo Medical Instrument Co., Ltd. | China | Maker | Endo Holder | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EJB / HANDLE, INSTRUMENT, DENTAL | — | — |
| G.A. Surgical (Pvt.) Ltd. | Pakistan | Maker | Handle with Mirror | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Mouth Mirror Handles | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | SS dental surgical blade/dental instruments | — | — |
| Goldman Products, Inc. | United States | Maker | Goldman · Micro-Dent | — | — |
| Silver Plus Corp. | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| BH Medical Products Co., Ltd | China | Maker | Micro Brush Applicators | — | — |
| NuCare LLC | United States | Maker | Micro Applicator | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | HANDLE | — | — |
| Surgiscape | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EJB - HANDLE, INSTRUMENT, DENTAL | — | — |
| Bioclear Matrix Systems, LLC | United States | Maker | Diamond Wedge | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | PUNCH, BIOPSY, SURGICAL | — | — |
| Choose Surgical Instruments | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Mident Ltd | United Kingdom | Maker | — | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | C-HANDLE-Endo File Holder | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Micro Applicators | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Intra oral tip | — | — |
| Nadir & Co. | Pakistan | Maker | Scalpel Handles | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Hand Instruments Handles | — | — |
| Daddy D Pro | Pakistan | Maker | Dental Mirror Handles | — | — |
| Mount Blonck Trading | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | SureTact G3 Wedge; SureTact Classico Wedge; SureTact Woodwedge; | — | — |
| LM-Instruments Oy | Finland | Maker | ErgoAccess · ErgoMix · LM-DENTAL · LM-LiftOut · +4 | — | — |
| Pilotis Tech LLC | United States | Maker | Intrace USA | — | — |
| B. Braun Medical Industries Sdn. Bhd | Malaysia | Maker | Handle | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Mian Shahid Corp. | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA CHEEK RETRACTOR · DENTORAMA INTERDENTAL BRUSHES · DENTORAMA JUMBO NAPKIN HOLDER · DENTORAMA WOODEN WEDGES | — | — |
| Zirc Dental Products Inc | United States | Maker | Ergo Grip Cone Socket Mirror Handle · Ergo Grip Simple Stem Mirror Handle · Soft Grip Cone Socket Mirror Handle | — | — |
| Tecomet | United States | Maker | PFR | — | — |
| Erskine Dental | Australia | Maker | Master Wedge · Piksters Interdental Brush Gap Sizing Probe | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | intra oral tip | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | Handle | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | BONE EXPANDER · SPLIT & SINUS MASTER | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Armatech International | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Nobil Metal S p A | Italy | Maker | LV ACC | — | — |
| Sabokay Industries | Pakistan | Maker | Handle, Instrument, Dental | — | — |
| Darleys Surgical Co. | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Hazel Enterprises | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Surgikare | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| T.A. Walthem & Company | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Washington Surgical International | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Madina Surgical Works | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Alvi Expo | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Oral photodynamic therapy device ModeLight PDT 630, Light PDT B | — | — |
| Hospimed Mfg | Pakistan | Maker | Handle Instruments, Dental | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Nawaz and Sons | Pakistan | Maker | EJB / HANDLE, INSTRUMENT, DENTAL | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | Valve, Snap on tips, Lever, Tip Accessories | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| Concise Enterprises | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| NR Surgical Company | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Tim J. Prusaitis | United States | Maker | PRU-DENT Dental Instruments · PRU-DENT MFG., INC. · PRU-DENT Retipping Service | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Swengg Co | Pakistan | Maker | Handles & Hand Held Dental Instruments | — | — |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | China | Maker | — | — | — |
| Chung Song Industrial Co. | South Korea | Maker | SUNBURST | — | — |
| E Hahnenkratt GmbH | Germany | Maker | HAHNENKRATT-HANDLES | — | — |
| Glorious Mercantile Corp. (Pvt.) Ltd. | Pakistan | Maker | DEVICE | — | — |
| Quality Concept (Pvt.) Ltd. | Pakistan | Maker | HANDLE, INSTRUMENTS, DENTAL | — | — |
| Empire Surgical Instruments Company | Pakistan | Maker | EMPSURG | — | — |
| Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. | Brazil | Maker | INDUSBELLO | — | — |
| Jay-Med | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Magenta Technology International Limited | China | Maker | Stainless Dental Tools (Tonge Scraper, Dental Tweezers, Dental Mirror), Stainless Acne Needle Kit | — | — |
| Dongguan Xinletian Dental Equipment Co., Ltd. | China | Maker | Temporary Anchorage Device Instrument | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS HANDLE, INSTRUMENT, DENTAL | — | — |
| Complexus Medical | United States | Maker | Rapidfire Upper Driver Assembly | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Zentro Enterprise Pvt. Ltd. | India | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Curaden AG | Switzerland | Maker | Power Duo | — | — |
| Industria Zingardi srl | Italy | Maker | Hydrosonic · Samba | — | — |
| A Fone Surgico | Pakistan | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Allied Medical LLC | United States | Maker | ETHER PUMPS · GOMCO SUCTION | — | — |
| Daekwang Idm | South Korea | Maker | HANDLE, INSTRUMENT, DENTAL | — | — |
| Evidence Implant Inc. | South Korea | Maker | — | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Shanwei Perfect Medical Instruments Co.,Ltd. | China | Maker | Gutta Percha Cutting Pen | — | — |
| YI Shing Co. Ltd. | Hong Kong SAR China | Maker | Dentool | — | — |
| Kazan Medical Instruments Plant Joint Stock Compan | Russia | Maker | Handle | — | — |
| Contech Holdings LLC | United States | Maker | tooth slooth | — | — |
| Instrumental Machine & Development | United States | Maker | N/A | — | — |
| Orthopli Corp. | United States | Maker | — | — | — |
| Sanctuary Health Sdn Bhd | Malaysia | Maker | — | — | — |
| Specialized Care Company | United States | Maker | CORBIN HVE Adapter | — | — |
| Auxein Medical Pvt Ltd | India | Maker | AUXEIN MEDICAL PVT LTD | — | — |
| Creative Dental Concepts LLC | United States | Maker | QwikStrip | — | — |
| HErD Star Company, Inc. | United States | Maker | HErD Star | — | — |
| Orchid Orhopedics | United States | Maker | Driver Handle | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Speedway Surgical Co. | India | Maker | handle, instrument | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Xinhua Surgical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Autocam Medical | United States | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Bailey Instruments Ltd | United Kingdom | Maker | — | — | — |
| Coda Resources Ltd., Heze China | China | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Erchinger | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| HGR Instrumente GmbH | Germany | Maker | — | — | — |
| Miing Wei Co., Ltd. | Taiwan | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Oertel Medical GmbH | Germany | Maker | — | — | — |
| Sinntech Medical (Private) Limited | Pakistan | Maker | — | — | — |
| Wise Instruments | Pakistan | Maker | — | — | — |
| Voco GmbH | Germany | Foreign exporter | AC Activator · AC Applicator · application cannulae · Brush holder · +9 | 117 | 2026 |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | HANDLE INSTRUMENT | 94 | 2026 |
| Ultradent Products, Inc. | United States | Contract manufacturer | Fischer's Ultrapak Packer · Halo Sectional Matrix Forceps · Halo Sectional Matrix Tweezers · Ultradent Slide Packer | 95 | 2026 |
| Kulzer, LLC | United States | Contract manufacturer | Kulzer PLT Applicator | 37 | 2026 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Composite Pacement Instruments | 27 | 2024 |
| Den-Mat Holdings, LLC | United States | Manufacturer | AdvantEdge · DualForce Matrix Forceps | 8 | 2026 |
| Dentatus USA Ltd. | United States | Repacker / relabeler | Profin | 4 | 2004 |
| G&H Wire Company | United States | Contract manufacturer | n/a | 2 | 2008 |
| GC Orthodontics | United States | Manufacturer | DS Interproximal Reduction | 2 | 2015 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | A. TITAN INSTRUMENTS | 1 | 2006 |
| Sotera Health LLC | United States | Contract manufacturer | Handle, Instrument, Dental | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Cone Stainless Steel Socket Mirror Handle, Round | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | Angelus | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Hand instrument | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | HANDLE, INSTRUMENT, DENTAL | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Mirror Handles | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental instrument | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Dental Mixing Spatula and Mixing Pads · Premium Plus Dental Disposable Napkin Holder · Premium Plus Hand Instruments · Premium Plus Micro Applicators | — | — |
| Pascal International | United States | Contract manufacturer | BK Probe · C-IPC Composite Placing Instrument · C-IPC/Off Angle Composite Placing · C-Plugger Composite Placing Instrum · +8 | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX USA | — | — |
| Identa Dental Material GmbH | Germany | Contract manufacturer | IDENTA AC Activator · IDENTA AC Applicator · IDENTA Application Brushes for root canal · IDENTA Application Cannulae · +7 | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3 Micro Applicators | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Handle | — | — |
| ArtCraft Dental, Inc. | United States | Repacker / relabeler | Matrix Gripper · spotOn | — | — |
| YCH Distripark Sdn Bhd | Malaysia | Foreign exporter | Handle | — | — |
| E A Beck & Company | United States | Repacker / relabeler | HANDLE, INSTRUMENT, DENTAL | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Valve, Snap on tips, Lever, SE Tip Accessories | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | RW | — | — |
| DOC BRANDS, Inc. | United States | Repacker / relabeler | Dentemp Professional Oral Care Kit | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | — | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL HANDLE | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Micro Applicators | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | disposable dental kits | — | — |
| Peak Implements Inc | United States | Repacker / relabeler | HANDLE, INSTRUMENT, DENTAL | — | — |
| Med Saver, Inc. | United States | Repacker / relabeler | MSI Precision Specialty Instruments | — | — |
| Magnum Medical | United States | Repacker / relabeler | Dental Handle | — | — |
| Common Sense Dental Products | United States | Repacker / relabeler | FlexiWedge · FlexiWedge Curve | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Olulo LLC | United States | Repacker / relabeler | — | — | — |
| Coda Resources Ltd | United States | Lister | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Wise Instruments Inc | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 8 Jul 2014 | K140144 | BENDA WEDGE | Centrix, Inc. |
| 25 Jun 2003 | K023367 | DETECTAR, MODEL N123-MI | Neks Technologies, Inc. |
| 5 Jun 1998 | K981234 | FLARE,FILE, FILL | Lone Star Technologies |
| 20 Oct 1993 | K930094 | AUKUSLEEVE | Aukland Medical Plastics, Inc. |
| 6 Aug 1992 | K922633 | CAVI-ZYME | E&D Dental Products, Inc. |
| 2 Jul 1987 | K871818 | SPATULA, DENTAL, CEMENT | Military Engineering, Inc. |
| 25 Nov 1983 | K833338 | TOOTH SLOOTH | Joel Lander D.D.S. |
| 26 Jan 1983 | K823913 | SOFT GRIP UNI-HANDLE | Treace Medical, Inc. |
Official records: FDA product classification for EJB · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026