Orthodontic wires & bands: manufacturers and brands
163 companies make or specify orthodontic wires among the 220 that list one with FDA, under 3,200 brand and model names. FDA has issued 75 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Orthodontic wire 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 |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | SureSmile Wires | 148 | 2026 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| American Orthodontics | United States | Maker | Band Material · Ball Retainer Clasps · Beta Titanium Wire · Everwhite Wire · +74 | 44 | 2026 |
| Vivos Therapeutics, Inc. | United States | Maker | Vivos DNA Appliance | 3 | 2024 |
| Modern Dental Laboratory Co., Ltd. | China | Maker | Orthodontic Appliance | 2 | 2024 |
| Ortho Organizers, Inc. | United States | Maker | ANDREWS2 ARCHWIRE · ARCHWIRE RETAINER · AUSSIE STAINLESS STEEL WIRE · BETA III ARCHWIRES · +188 | 8 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | ACR · NLT-LE · NLT-LES · NLT9-EH · +37 | 5 | 2023 |
| Tp Orthodontics, Inc. | United States | Maker | Aesthetic Nickel-Titanuim Preformed Archwire · Aesthetic Stainless Steel Preformed Archwire · Bio-Arch Wires · Bow-Flex Archwire · +55 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | BIOSTELL · LEOLOY · LEOWIRE · MEMORIA · +5 | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Ze Fang Technology Co., Ltd. | Taiwan | Maker | Kobayashi Pre-cut Ligature Ties-012 · Kobayashi Stainless Steel Ligature Ties-012 · Kobayashi Stainless Steel Ligature Ties-014 · New Cu-Niti13 Universal Form · +261 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Arch Wire/Straight Wires · Buccal Tubes/ · Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics · Molar Bands · +1 | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Deltajet · NIC · Superfile · Target | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | WIRE, ORTHODONTIC; profa wires | 1 | 2023 |
| MK Meditech | South Korea | Maker | ATOZ Utility Wire | 1 | 2021 |
| Celebrace | United States | Maker | Celebrace AI Wire | 1 | 2025 |
| Reliance Orthodontic Products, Inc. | United States | Maker | Bond A Braid · C&C · Extend · Kobayashi Tie Hooks · +5 | 32 | 2021 |
| Aseptico, Inc. | United States | Maker | AMA-09A - KIT CUSPID CHAIN / GRID · AMA-09A2 - KIT BICUSPID CHAIN / GRID · AMA-09A3 - KIT INCISOR CHAIN / GRID · AMA-09D - LINGUAL BUTTONS PKG/6 | 17 | 2015 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Ortho Kinetics Corp. | United States | Maker | Power Coins Glow in the Dark Ligatures | 7 | 1998 |
| Ultimate Wireforms, Inc. | United States | Maker | Advanced Thermal · BII-CNA · Black-Ti · CTA · +8 | 6 | 1996 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Mediloy RPD | 4 | 2013 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic wires and arch wires · Flat- Line Buccal Tubes · Orthodontic Molar Bands · Orthodontic Spring | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho · WIRE · TUBE · BAND, ELASTIC · +1 | 3 | 2021 |
| Gergens Orthodontic Lab | United States | Maker | Vivos DNA Appliance | 3 | 2017 |
| Hdc S.R.L. | Italy | Maker | Orthodontic Anchorage Attachment | 3 | 2009 |
| Dentos, Inc. | South Korea | Maker | LAB-100-12 · LAB-100-500 · LAB-120-12 · LAB-120-500 · +746 | 2 | 2019 |
| G&H Wire Company | United States | Maker | A.J. Wilcock® · A.J. WILCOCK® AUSTRALIAN WIRE · A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE · A.J. WILCOCK® TRUEFORM AUSTRALIAN WIRE SOLO-PACK · +97 | 2 | 2008 |
| GC Orthodontics | United States | Maker | GC Orthodontics · GC Ortho | 2 | 2015 |
| ORTHO-TAIN, Inc. | United States | Maker | CLASS III GUIDE · HABIT-CORRECTOR · HAWLEY-FORM · INTERIM "G" RETAINER · +10 | 2 | 1998 |
| World Bio Tech Co Ltd | South Korea | Maker | SMART Wires ; NiTi Archwire, Stainless Steel Archwire, Copper NiTi Archwire, Reverse Curve NiTi Archwire · Elastomerics ; Intraoral Elastics, Power Chain, Ligature Ties, Separators, Thread, Tubing, Rotation Wedge · Niti Closed coil spring, Niti Open coil spring Torquing Spring | 2 | 2016 |
| Acme-Monaco Corp. | United States | Maker | MULTIPLE PRODUCTS | 2 | 1990 |
| Brius | United States | Maker | Brava | 2 | 2021 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| HT Co., Ltd. | South Korea | Maker | MISO NiTi Dimpled Archwire MDL-14 · MISO NiTi Dimpled Archwire MDL-16 · MISO NiTi Dimpled Archwire MDL-1616 · MISO NiTi Dimpled Archwire MDL-1622 · +138 | 1 | 2011 |
| Rmo, Inc. | United States | Maker | Truform · Bendaloy Titanium, Niti Coil Spring; Elgiloy; FLI Copper and FLI Aesthetic; Orthonol, Thermaloy Plus · Thermaloy Nickel Titanium Wire; RMLocks, Hooks, Other Accessories; SWLRF Wires; TRU-CHROME Stainless Steel · Orthodontic Tubes · +2 | 1 | 1990 |
| World Class Technology Corporation | United States | Maker | Duraband · Fierro · orthodontic band · orthodontic wire · +4 | 1 | 2019 |
| Sawbros Industries Pvt., Ltd. | India | Maker | Lingual Retainer Wire · Lingual Retainer Wire Titanium · Stainless Steel Wire · SEPARATOR, ORTHODONTIC | 1 | 2017 |
| Bioseal | United States | Maker | sterile bands | 1 | 1988 |
| ASO International Manila, Inc. | Philippines | Maker | Double Tube (DT) · Tube for Forsus · Customized Bands | 1 | 2021 |
| Hespeler Orthodontics Ltd | Canada | Maker | COAXPF16 · COAXPF18 · DNTAW18X18LL · DNTAW18X18LM · +464 | — | — |
| Zain's Medical Image | Pakistan | Maker | Aspirator Tip · Surgical Aspirator Tips | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Dental stainless steel wire 30g 0.5mm/0.6mm/0.7mm/0.8mm/0.9mm/1mm/1.2mm/1.8mm · Dental stainless steel wire 50g 0.5mm/0.6mm/0.7mm/0.8mm/0.9mm/1mm · Ligature wire 0.2mm/0.25mm/0.30mm/0.40mm | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Crozat Special wire · Crozat wire · Dentaflex · dentaflex arch wire · +46 | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Alf · Anterior Growth Appliance · Anterior Growth/Jet Sagittal · Bi-Metric Distalizing Arch · +45 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Orthodontic Arch Wire · Arch Wire · bandage · Elastane Chain · +21 | — | — |
| Digital Dental Laboratories, Inc. DBA Orthodent | Canada | Maker | Molar Tubes · CS 2000 · Distal jet · Distal Jet 2 Bands · +68 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Arch Wire/Straight Wires/ · Buccal Tubes · Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics, Elastane chain · Molar Bands · +1 | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ORTHOMETRIC BANDS · BIOVERSATIL ARCHWIRES · FLEXY NiTi - ARCHWIRES KIT · FLEXY NiTi COPPER - CuNiTi · +41 | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Arch Wires · Ligature Ties · Power Chains · Elastic Placers | — | — |
| Denovo Dental Inc | United States | Maker | D071514 · D071515 · D071516 · D071517 · +4 | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | WIRE ORTHODONTIC | — | — |
| Aesculap AG | Germany | Maker | ORTHODONTIC WIRE | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Westlake · Wire, Orthodontic · Wire, Orthodontic (All type of NITI and Stainless Steel wire and Springs) · Tube, Orthodontic · +7 | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | BAND, ELASTIC, ORTHODONTIC · BAND, PREFORMED, ORTHODONTIC | — | — |
| Aditek do Brasil SA | Brazil | Maker | Arcos Braided · Arcos de Aço · Arcos de Retração · Arcos Dupla Chave · +21 | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | Orthodontic Wire · B103-21 Bondable 1st Convertible Slot 022 Edgewise Buccal Tube; · B104-11 Bondable 1st Non-Convertible Slot 018 Edgewise Buccal Tube; · B104-21 Bondable 1st Non-Convertible Slot 022 Edgewise Buccal Tube; · +16 | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | BK MASK blue · BK MASK ivory · BK MASK violet · FACEMASK BL Org · +21 | — | — |
| Solventum US LLC | United States | Maker | Hi-T · Incognito · Unitek · Unitek (TM) Bands · +5 | — | — |
| Surgicrafts | Pakistan | Maker | ECM / BAND, PREFORMED, ORTHODONTIC | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | SIA ORTHODONTIC MANUFACTURER · I-ARCH · MACH3 · JET · +3 | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Orthodontic Arch Wire · Orthodontic Rubber Chain and Ligature Tie | — | — |
| Innovative Material And Devices, Inc. | China | Maker | 1st Molar Etched Interior, 2nd Molar Etched Interior · Braided Wires, NiTi Super Elastic Wires, NiTi Super Elastic RCS Wires, NiTi Thermal Active Wires, · Cu-Alloy Tri MEMAlloy Wires, NiTi Coated Wires, Stainless Steel Coated Wires · NiTi Tri MEMAlloy Wires, MEMAlloy Wires, Bio MEMAlloy Wires, Beta-Ti Wires, Cu-Alloy NiTi Wires, · +6 | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Orthodontic arch wire,Orthodontic band,Orthodontic buccal tube · Polishing brush,Elastance chain,Ligature tie,Orthodontic Bracket,tooth model,Orthodontic kit · Separator elastormeric,probe (forceps),Orthodontic elastic | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect · Eurodonto · Protect | — | — |
| Nadir & Co. | Pakistan | Maker | Tube Holding Forceps | — | — |
| Produits Dentaires SA | Switzerland | Maker | Matrix bands | — | — |
| Astar Orthodontics Inc | China | Maker | band · Ligature wire · Niti wire · Stainless Steel wire · +11 | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Brace elastics | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | — | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | TUBE, ORTHODONTIC · BAND, ELASTIC, ORTHODONTIC | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodontic Wire · Orthodontic Tube · Orthodontic Band · Spring, Orthodontic | — | — |
| Specialty Appliances, LLC | United States | Maker | G4 NiTi Lingual Wire · SurgiArch · Archwire Tubes · Orthodontic Bands | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Band.Material. Orthodontic · Tube, Orthodontic · Band, Elastic, Orthodontic | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Orthodontic Wires (WIRE, ORTHODONTIC; Profa Wires) | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Band, Orthodontic · Niceortho Wire, Orthodontic · Niceortho TUBE, ORTHODONTIC · Niceortho Band, elastic, orthodontic · +2 | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Orthodontic Wire CHIRMED | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | Clear aligner | — | — |
| Scheu-Dental GmbH | Germany | Maker | CHROMIUM Wire · MENZANIUM Wire | — | — |
| Zhongshan Xinhe Co.,Ltd | China | Maker | Wire, Orthodontic | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic bands · Orthodontic wire · Orthodontic buccal tube · Orthodontic spring | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Band, Material, Orthodontic · Orthodontic wire Models COLOR CODE, SS,NITI,BETA-II,COIL-I · Orthodontic Tube | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Orthodontic Braket, Orthodontic Buccal Tube, Orthodontic Elastic, Orthodontic Arch Wires, Dental Teeth Model, · Orthodontic Kit | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Band Material · Orthodontic Wire · Orthodontic Tube · Orthodontic Elastic Band · +2 | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental, Orthodontic seperators · OO Dental · OO Dental, O-Tube · OO Dental, Orthodontic ligature ties · +2 | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT ORTHODONTIC WIRE - 1DERFUL ORTHODONTIC WIRE · SKY DENT ORTHODONTIC TUBE - 1DERFUL ORTHODONTIC TUBE · SKY DENT ORTHODONTIC BAND - 1DERFUL ORTHODONTIC BAND | — | — |
| Win Wings Corp. | Pakistan | Maker | TUBE, ORTHODONTIC | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | Orthodontic Wires | — | — |
| CM Instrumente GmbH | Germany | Maker | CM -Instrumente · CM ORTHODONTIC WIRE | — | — |
| Sino Ortho Limited | China | Maker | Molar band · preformed wire, orthodontic · buccal tube, molar tube · orthodontic elastic, tie · +1 | — | — |
| Alframed | Pakistan | Maker | WIRE, ORTHODONTIC · surgical aspirator, 2.5mm tip | — | — |
| Asanus Medizintechnik GmbH | Germany | Maker | ASANUS | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | Orthomechanics · Smart | — | — |
| Waqas Surgical Instruments | Pakistan | Maker | fraizeir tube · fraizeir tube/needle · Pool section tube · younker tube, | — | — |
| Zhejiang Headway Medical Equipment Co., Ltd. | China | Maker | Orthodontic Archwires · Orthodontic Buccal Tubes · Orthodontic Bands | — | — |
| Garnet Dentech | South Korea | Maker | Face Mask · Orthodontic Wire | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Band, Material, Orthodontic · Wire, Orthodontic · Tube Orthodontic · Angsheng, Orthodontics World · +1 | — | — |
| O&S Dental Inc | United States | Maker | Orthodontic Tubules · Top Elastics, Top Chain, Top Sticks, Separators · Spring | — | — |
| United Dental Changzhou | China | Maker | Orthodontic Stainless steel Wires, Orthodontic Niti Wires | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Orthodontic Band · Wire, Orthodontic · Orthodontic Tube · Elastic Orthodontic Band · +1 | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Wire · Orthodontic Tube · Orthodontic Elastics · Orthodontic Band | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | WIRE · TUBE · BAND · SPRING | — | — |
| American Angle Ortho, LLC | United States | Maker | Buccal Tubes orthodontics · Donuts Elastic, Donuts Elastomeric Ligature Ties, Donuts Power Chains, · Donuts Rotaition Wedges, Donuts Bumper Tubing, Donuts Separators | — | — |
| Funing Meitedental Factory | China | Maker | Orthodontic Wires · Orthodontic buccal tube · Orthodontic bands, Latex Elastics, Orthodontic elastomeric, Orthodontics Elastics, Ligate Ties, Power Chain | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Dental Tubes;Buccal Tubes;DTC;Orthodontics · Dental Bands;DTC;Orthodontics · DTC;Orthodontics | — | — |
| Libral Traders Pvt Ltd | India | Maker | Niti Wires, SS Wires, Beta Wires, Wire Forms · Elastomeric Archwire Tubing, Intraoral Extraoral Elastics, Ligature Ties, Separators | — | — |
| Modern Orthodontics | India | Maker | Tinol-1, Tinol-2, TiNol-RC, TiNol-TQ, Tinol-3F,Acti-4S, Ti-Alloy, Micro-Kot · ELFIN, AFIX · ElastoSure · AccuForm · +1 | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | orthodontic wires · orthodontic buccal tube · ligature tie orthodontics/orthodontic elastic rubber bands/power chain/Orthodontic Elastic Band/ · Orthodontic Appliance and Accessories · +1 | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | WIRE, ORTHODONTIC · TUBE, ORTHODONTIC · Band, elastic, orthodontic · BAND, PREFORMED, ORTHODONTIC | — | — |
| Tangent Technologies LLC | United States | Maker | Orthodontic Wire and Archwires-Beta Titanium (Beta Ti); Nickel Titanium (NiTi) ; Stainless Steel (SS) ; Nickel Cobalt · Orthodontic Buccal Tubes and Orthodontic Metal Tubes · Elastic Separators; Elastic Thread; Elastics; Energy Chain; Elastomeric Ligatures; Rotation Wedge · Orthodontic Bands · +1 | — | — |
| Xingyue Medical Health Technology (Nanjing) Co., Ltd . | China | Maker | Orthodontic Protective Wax · Orthodontic Rings | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS · Tecnident | — | — |
| Hansfive (Hangzhou) Dental Technology Co., Ltd. | China | Maker | Orthodontic Wire · Buccal Tubes · Orthodontic Band · Orthodontic Spring | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Orthodontic arch wire · Buccal tubes · Orthodontic elastic | — | — |
| Dongguan Xinletian Dental Equipment Co., Ltd. | China | Maker | Dental Stainless Steel Wire | — | — |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd | China | Maker | Hangzhou Xingchen 3B Dental Instrument & Material Co., Ltd. · Hangzhou 3B · Ortho Elastics · hangzhou 3B | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Orthodontic Wire · Orthodontic Tube · Orthodontic Elastic Band · Orthodontic Spring | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Alta Smiles, Inc | United States | Maker | Alta-Flex · Prowire | — | — |
| Creative Dental | China | Maker | Wires · Tube · Band Elastic · Band | — | — |
| Shenzhen HLD Dental&Technology Co.,Ltd | China | Maker | DENTAURUM | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Orthodontic Wire · Buccal Tube · Orthodontic Elastics | — | — |
| Yangjiang Kaimi Import Export Co.,Ltd | China | Maker | BAND, MATERIAL, ORTHODONTIC | — | — |
| Shenzhen Times Dental Lab | China | Maker | Times Dental Custom Restorations | — | — |
| JINHUA GLAMB MEDICAL EQUIPMENT Co., Ltd. | China | Maker | Buccal Tubes · Orthodontic Elastomerics | — | — |
| Mothers Medica Private Limited | India | Maker | Nanoalign | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | orthguide | — | — |
| Progressive America Inc | United States | Maker | Medit Orthodontic Suite | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Yancheng Denrum Medical Apparatus Co Ltd | China | Maker | Orthodontic Archwire · Orthodontic Elastomer · Orthodontic Bands | — | — |
| Chikami Miltec Inc. | Japan | Maker | Q.C.M. RETAINER WIRE · (RWS-42, RWS-48, RWS-54, RWL-42, RWL-48, RWL-54, RWL-W50) · (RWS-P36, RWL-P36, RWS-P50, RWL-P50) | — | — |
| Jin Hsiang Enterprise Co., Ltd. | Taiwan | Maker | Custom Orthodontic Tubes | — | — |
| Lorelli Technologies LLC | United States | Maker | InSmile Braces Orthodontic System | — | — |
| Ricomed LLC | United States | Maker | RICOmed tubes | — | — |
| Aegion Technologies Inc | United States | Maker | Ortavia Arch Wires | — | — |
| Auradonics Inc | United States | Maker | BAND · , elastic, orthodontic | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| Dickerson Orthodontics | United States | Maker | D2 Appliance | — | — |
| HeiLongJiang Rainbow Technology Co., Ltd. | China | Maker | Orthodontic Wire · Orthodontic Spring | — | — |
| Matrix Health, Inc. | United States | Maker | ORTHODONTIC SPRING · GTS | — | — |
| MPL Manufacturing Inc. | United States | Maker | Metal Band | — | — |
| Ortho Traction Pads | United States | Maker | — | — | — |
| Smarter Alloys Inc | Canada | Maker | SmartArch | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | Orthodontic Elastics including separator, power chain, O-ring, Elastic etc | — | — |
| Allure Ortho | United States | Maker | — | — | — |
| COHO Advanced Materials Tech. Co., Ltd. | Taiwan | Maker | "COHO" Orthodontic appliance and accessories | — | — |
| DANY BMT Co., Ltd. | South Korea | Maker | Orthodontic wire | — | — |
| proNet, A Desco Industries Inc. Brand | United States | Maker | — | — | — |
| Sichuan Yaqi Medical Technology Co., Ltd. | China | Maker | Dental Sheet | — | — |
| Snapz Innovations Inc | United States | Maker | Snapz Tasty Bands | — | — |
| Taurus Engineering and Manufacturing, Inc. | United States | Maker | — | — | — |
| Wire and Cable Specialties Inc | United States | Maker | Multiple - Industry Generic Names | — | — |
| Zalinsky Ortho Parts, LLC | United States | Maker | Isoglide | — | — |
| Eagle Mold Technologies, Inc. | United States | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Icp, Inc. | United States | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Polymer Engineering Laboratories Ltd. | Japan | Maker | — | — | — |
| Yuwa Seisakusho KK | Japan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Orthodontics Springs and Wires · Orthodontics, Tube · Orthodontics Springs | 23 | 2025 |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Myofunctional Research Co. Usa Inc. | United States | Foreign exporter | Lingual Tubes BWS · BWS Band | 3 | 2026 |
| EC Certification Service GmbH | Austria | Manufacturer | — | 1 | 2025 |
| Hu-Friedy Mfg Co., LLC | United States | Contract manufacturer | Hu-Friedy Mfg. Co., LLC | 8 | 2012 |
| Biomet Microfixation | United States | Manufacturer | Arch Bar · Prestretched Wire · Wire · Orthodontic Band · +1 | 8 | 2021 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex · Padgett | 2 | 2014 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | DB Orthodontics Archwire · DB Orthodontics Archwire (Reel) · DB Orthodontics Wire Ligatures · Straight 8 Retainer Wire · +8 | 2 | 2010 |
| Sotera Health LLC | United States | Contract manufacturer | Band, Elastic, Orthodontic · 14002/100 · 14004/100 · 14005/100 · +65 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | BUCCAL TUBE · orthodontic tube · dental elastic. · dental Speparator · +3 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM · TORINO IMPORT AND EXPORT LIMITED | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Jmu · JMU Intra Oral Latex Elastics · JMU Intra Oral Latex Free Elastics · JMU JMU Intra Oral Elastics Neon · +8 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Super Elastic Nickel Titanium Arch Wire · Patterson® Nonconvertible Direct Bond Tubes · Patterson® Plastic Ligature · Patterson® Plain First Molar Bands | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | alpha wire NiTi coated · alpha wire NiTi super elastic · alpha wire stainless steel wire · alpha wire stainless steel wires coated · +19 | — | — |
| Practicon, Inc. | United States | Manufacturer | PRACTICON LIGATURE TIES | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Adams Clasps · Archwire · Arrow Anchors · Arrow Clasps · +20 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Exceloy · IOS SS · Koby Ligature wire Long / Short sizes 010 /012 /014 · Ligature Wire SS Long size 008 to 014 · +21 | — | — |
| Orthoworld, L.L.C. | United States | Repacker / relabeler | Fastbraces® Aesthetic Archwires · Fastbraces® Classic Metal Archwires · Fastbraces® Combo Archwires · Fastbraces® Combo-Turbo Archwires · +5 | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | AJ Wilcock Australian Wire 25" Spool and 14" Length Wire · Beta Titanium · Black Satin SE Niti · Brehm Niti Utility Arch · +21 | — | — |
| Csy International LLC | United States | Repacker / relabeler | Caber · J&J Ortho · J&J Orthodontics | — | — |
| Forestadent Usa | United States | Repacker / relabeler | WIRE · Alexander · Andrews · Aspire · +14 | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Contract manufacturer | Duralloy Wire · Great Lakes Stainless Steel wire · Titanium Molybdenum | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | band, material, orthodontic · Wire, Orthodontic · Tube, Orthodontic · Band, Elastic, Orthodontic · +1 | — | — |
| battech | United States | Repacker / relabeler | dental arch wire, Stainless Steel Kobyashi Wire, Braces Wire, Orthodontic Dental Ligature Wire · dental buccal tube · orthodontics elastic band | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Orthodontic Arch Wire,Orthodontic Band,Orthodontic Buccal Tube · Polishing Brush,Elastance Chain,Ligature Tie,Orthodontic Bracket,Tooth Model,Orthodontic Kit · Separator Elastormeric,Probe (Forceps),Orthodontic Elastic | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Innova · meridian · Novis · vortex · +3 | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Orthodontic Band · Orthodontic Wire · Orthodontic Tube · Elastic Band · +1 | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | NITI WIRE · SS WIRE · TIBEND WIRE · ANCHOR BUCCAL TUBE · +7 | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Copper NiTi Archwire · Advance NiTi Super-Elastic Reverse Curve Archwire · Advance Stainless Steel Archwire · Advance Precision Premium Bonding Tubes · +6 | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix Convertible Buccal Tubes · Phoenix Optimal · Endura High Performance Chain · Spectrum Elastomerics · +6 | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Professional Surgical Instruments Co., Inc. | United States | Manufacturer | Arch wires · Orthodontic Wires · Wires | — | — |
| Saga Dental Supply A | Norway | Contract manufacturer | Band · band | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Preformed Ortho Band | — | — |
| SurgiPros LLC | United States | Repacker / relabeler | SURGIPROS | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | Dental Sheet | — | — |
| Mirabay Orthodontics Corporation | United States | Repacker / relabeler | Symmetry Archwires · KLEOS COMFY BUCCAL TUBES · KLEOS PSL BUCCAL TUBES · Mirabay Elastomeric · +1 | — | — |
| Showcase Dental Lab LLC | United States | Contract manufacturer | Ortho Products | — | — |
| JM Ortho Corporation | Japan | Foreign exporter | Energy Chain · Energy Thread · K-2 O-Ring · Tough-O | — | — |
| Cx Orthodontic Supply | United States | Repacker / relabeler | CX Ortho Supply | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Pg Supply, Inc. | United States | Repacker / relabeler | Pg Supply | — | — |
| Advanced Orthodontic Solutions | United States | Repacker / relabeler | 304V Stainless Steel Orthodontic Wire | — | — |
| Modern Arch Corp. | United States | Repacker / relabeler | orthodontics | — | — |
| SDP Inc. | Canada | Repacker / relabeler | SDP ELASTIC BAND | — | — |
| Yiwu Daqida Plastic Products Co., Ltd. | China | Foreign exporter | Mouth Guard | — | — |
| Cardinal Health 200, LLC | United States | Manufacturer | — | — | — |
| DentOrtho LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Toyo Polymack Co., Ltd. | Japan | Foreign exporter | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where orthodontic wires 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 |
|---|---|---|---|---|
| Orthodontic WireDZC | 1 | 872.5410 | 117 | 30 |
| Orthodontic TubeDZD | 1 | 872.5410 | 79 | 8 |
| Orthodontic Elastic BandECI | 1 | 872.5410 | 74 | 25 |
| Orthodontic SpringECO | 1 | 872.5410 | 56 | 7 |
| Orthodontic Preformed BandECM | 1 | 872.5410 | 55 | 2 |
| Orthodontic Material BandDYO | 1 | 872.5410 | 34 | 3 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Nov 2011 | K112640 | HYPERELASTIC WIRE | Sybron Dental Specialties | DZC Orthodontic Wire |
| 20 Apr 1998 | K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Ortho Kinetics Corp. | ECI Orthodontic Elastic Band |
| 24 Feb 1998 | K980053 | GLENROE CHAIN | Glenroe Technologies | ECI Orthodontic Elastic Band |
| 1 Dec 1997 | K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | Glenroe, LLC | ECI Orthodontic Elastic Band |
| 24 May 1995 | K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | Jon-Ko Products, Inc. | ECI Orthodontic Elastic Band |
| 23 May 1995 | K943421 | ORTHODONITC ELASTOMERIC SLEEVING | Jon-Ko Products, Inc. | DZD Orthodontic Tube |
| 23 May 1995 | K943420 | ORTHODONTIC ELASTOMERIC CHAIN | Jon-Ko Products, Inc. | ECI Orthodontic Elastic Band |
| 23 May 1995 | K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | Jon-Ko Products, Inc. | ECI Orthodontic Elastic Band |
| 23 May 1995 | K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD | Jon-Ko Products, Inc. | ECI Orthodontic Elastic Band |
| 5 Oct 1994 | K943334 | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT | Jay H. Geller | DZC Orthodontic Wire |
| 17 Aug 1994 | K943068 | MAGNEFORCE | Sybron Dental Specialties | ECO Orthodontic Spring |
| 5 Aug 1994 | K933542 | MESIAL LOOP BAR | Gac Intl., Inc. | ECO Orthodontic Spring |
| 13 Jul 1994 | K942492 | ADJUSTABLE BITE CORRECTOR | Orthoplus, Inc. | ECO Orthodontic Spring |
| 18 May 1994 | K935638 | NITINOL, NITI | Highland Metals | DZC Orthodontic Wire |
| 7 Mar 1994 | K940165 | ALASTIK | Unitek Corp. | ECI Orthodontic Elastic Band |
| 14 Feb 1994 | K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. | ECI Orthodontic Elastic Band |
| 4 Feb 1994 | K935140 | DENTAURUM STEEL LIGATURE WIRES | Dentauraum, Inc. | DZC Orthodontic Wire |
| 4 Feb 1994 | K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. | ECI Orthodontic Elastic Band |
| 2 Feb 1994 | K936243 | REGENCY TUBE | Ortho Specialties | DZD Orthodontic Tube |
| 31 Jan 1994 | K935142 | DENTAURUM WIRES | Dentauraum, Inc. | DZC Orthodontic Wire |
| 31 Jan 1994 | K935143 | DENTAURUM STAINLESS STEEL TUBING | Dentauraum, Inc. | DZD Orthodontic Tube |
| 31 Jan 1994 | K935152 | DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD | Dentauraum, Inc. | DYO Orthodontic Material Band |
| 21 Jan 1994 | K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Flexmedics | DZC Orthodontic Wire |
| 19 Nov 1993 | K933374 | NITI COIL SPRINGS | Highland Metals | DZC Orthodontic Wire |
| 16 Nov 1993 | K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | Highland Metals | DZC Orthodontic Wire |
| 12 Nov 1993 | K933380 | REVERSE SURVE NITI ARCH WIRE | Highland Metals | DZC Orthodontic Wire |
| 12 Nov 1993 | K933379 | STAINLESS STEEL ARCHES | Highland Metals | DZC Orthodontic Wire |
| 12 Nov 1993 | K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | Highland Metals | DZC Orthodontic Wire |
| 12 Nov 1993 | K933376 | NITI ARCH WIRE ON A SPOOL | Highland Metals | DZC Orthodontic Wire |
| 20 Sep 1993 | K932319 | ORTHODONTIC ELASTOMER | Gac Intl., Inc. | ECI Orthodontic Elastic Band |
| 1 Sep 1993 | K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | Ortho Organizers, Inc. | DYO Orthodontic Material Band |
| 28 Jul 1993 | K931631 | COATED ORTHODONTIC DEVICES | Wonder Wire | DZC Orthodontic Wire |
| 22 Jul 1993 | K931462 | GLENROE CHAIN | Glenroe Technologies | ECI Orthodontic Elastic Band |
| 24 Jun 1993 | K923999 | ALASTIK NS | Unitek Corp. | ECI Orthodontic Elastic Band |
| 27 May 1993 | K930202 | TITAN SEPARATING SPRING | Ortho Spectrum, Inc. | DZC Orthodontic Wire |
| 27 May 1993 | K930453 | SINGLES | Nexadental | ECI Orthodontic Elastic Band |
| 27 May 1993 | K925163 | MICODOSE CHLORHEXIPREP | Unicep | ECM Orthodontic Preformed Band |
| 27 Apr 1993 | K924140 | TUFF TIES | Glenroe Technologies | ECI Orthodontic Elastic Band |
| 8 Apr 1993 | K924139 | GLENROE ORTHO SEPS | Glenroe Technologies | ECI Orthodontic Elastic Band |
| 31 Mar 1993 | K924805 | ORTHODONTIC ARCH WIRE | Ultimate Wireforms, Inc. | DZC Orthodontic Wire |