Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Wire
FDA device type “Wire, Orthodontic”.
- Companies listing it
- 161117 makers
- Brands and models
- 1,671
- 510(k) clearances
- 300 in five years
- FDA name
- Wire, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list DZC
161 companies currently list this device type with FDA.
| 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 | Ball Retainer Clasps · Beta Titanium Wire · Everwhite Wire · Force Two NiTi Wire · +18 | 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 · +82 | 8 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | ACR | 5 | 2023 |
| Tp Orthodontics, Inc. | United States | Maker | Aesthetic Nickel-Titanuim Preformed Archwire · Aesthetic Stainless Steel Preformed Archwire · Bio-Arch Wires · Bow-Flex Archwire · +16 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | BIOSTELL · LEOLOY · LEOWIRE · MEMORIA | 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 · +144 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Arch Wire/Straight Wires | 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 · +4 | 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 |
| Ultimate Wireforms, Inc. | United States | Maker | Advanced Thermal · BII-CNA · Black-Ti · CTA · +4 | 6 | 1996 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic wires and arch wires | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | WIRE | 3 | 2021 |
| Gergens Orthodontic Lab | United States | Maker | Vivos DNA Appliance | 3 | 2017 |
| Dentos, Inc. | South Korea | Maker | LAB-100-12 · LAB-100-500 · LAB-120-12 · LAB-120-500 · +707 | 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 · +70 | 2 | 2008 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| ORTHO-TAIN, Inc. | United States | Maker | PERFIT BUMPER | 2 | 1998 |
| World Bio Tech Co Ltd | South Korea | Maker | SMART Wires ; NiTi Archwire, Stainless Steel Archwire, Copper NiTi Archwire, Reverse Curve NiTi Archwire | 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 · +111 | 1 | 2011 |
| Rmo, Inc. | United States | Maker | 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 | 1 | 1990 |
| World Class Technology Corporation | United States | Maker | orthodontic wire | 1 | 2019 |
| Sawbros Industries Pvt., Ltd. | India | Maker | Lingual Retainer Wire · Lingual Retainer Wire Titanium · Stainless Steel Wire | 1 | 2017 |
| Hespeler Orthodontics Ltd | Canada | Maker | COAXPF16 · COAXPF18 · DNTAW18X18LL · DNTAW18X18LM · +126 | — | — |
| 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 · +16 | — | — |
| 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 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Arch Wire/Straight Wires/ | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | BIOVERSATIL ARCHWIRES · FLEXY NiTi - ARCHWIRES KIT · FLEXY NiTi COPPER - CuNiTi · FLEXY NiTi COPPER RHODIUM · +16 | — | — |
| 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) | — | — |
| Aditek do Brasil SA | Brazil | Maker | Arcos Braided · Arcos de Aço · Arcos de Retração · Arcos Dupla Chave · +13 | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | Orthodontic Wire | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | MTA Wire 012 NiTi · MTA Wire 014 NiTi · MTA Wire 35celsius thermo-active 012 NiTi · MTA Wire 40celsius thermo-active 012 NiTi · +1 | — | — |
| Solventum US LLC | United States | Maker | Hi-T · Incognito · Unitek | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | I-ARCH · MACH3 · SIA ORTHODONTIC MANUFACTURER | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Orthodontic Arch Wire | — | — |
| Innovative Material And Devices, Inc. | China | Maker | 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, · Stainless Steel Wires, Stainless Steel Straight Wires, Stainless Steel Australian Wires, Stainless Steel | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | Eurodonto · Protect | — | — |
| Astar Orthodontics Inc | China | Maker | Ligature wire · Niti wire · Stainless Steel wire | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | — | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodontic Wire | — | — |
| Specialty Appliances, LLC | United States | Maker | G4 NiTi Lingual Wire · SurgiArch | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | — | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Orthodontic Wires (WIRE, ORTHODONTIC; Profa Wires) | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Wire, Orthodontic | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Orthodontic Wire CHIRMED | — | — |
| 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 wire | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Orthodontic wire Models COLOR CODE, SS,NITI,BETA-II,COIL-I | — | — |
| 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 Wire | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT ORTHODONTIC WIRE - 1DERFUL ORTHODONTIC WIRE | — | — |
| 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 | preformed wire, orthodontic | — | — |
| Alframed | Pakistan | Maker | WIRE, ORTHODONTIC | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | Orthomechanics · Smart | — | — |
| Zhejiang Headway Medical Equipment Co., Ltd. | China | Maker | Orthodontic Archwires | — | — |
| Garnet Dentech | South Korea | Maker | Face Mask · Orthodontic Wire | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Wire, Orthodontic | — | — |
| United Dental Changzhou | China | Maker | Orthodontic Stainless steel Wires, Orthodontic Niti Wires | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Wire, Orthodontic | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Wire | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | WIRE | — | — |
| Funing Meitedental Factory | China | Maker | Orthodontic Wires | — | — |
| Libral Traders Pvt Ltd | India | Maker | Niti Wires, SS Wires, Beta Wires, Wire Forms | — | — |
| Modern Orthodontics | India | Maker | Tinol-1, Tinol-2, TiNol-RC, TiNol-TQ, Tinol-3F,Acti-4S, Ti-Alloy, Micro-Kot | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | orthodontic wires | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | WIRE, ORTHODONTIC | — | — |
| Tangent Technologies LLC | United States | Maker | Orthodontic Wire and Archwires-Beta Titanium (Beta Ti); Nickel Titanium (NiTi) ; Stainless Steel (SS) ; Nickel Cobalt | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | Tecnident | — | — |
| Hansfive (Hangzhou) Dental Technology Co., Ltd. | China | Maker | Orthodontic Wire | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Orthodontic arch wire | — | — |
| 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. | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Orthodontic Wire | — | — |
| Alta Smiles, Inc | United States | Maker | Alta-Flex · Prowire | — | — |
| Creative Dental | China | Maker | Wires | — | — |
| Shenzhen HLD Dental&Technology Co.,Ltd | China | Maker | DENTAURUM | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Orthodontic Wire | — | — |
| Shenzhen Times Dental Lab | China | Maker | Times Dental Custom Restorations | — | — |
| Mothers Medica Private Limited | India | Maker | Nanoalign | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Yancheng Denrum Medical Apparatus Co Ltd | China | Maker | Orthodontic Archwire | — | — |
| 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 | — | — | — |
| Lorelli Technologies LLC | United States | Maker | InSmile Braces Orthodontic System | — | — |
| Ricomed LLC | United States | Maker | — | — | — |
| Aegion Technologies Inc | United States | Maker | Ortavia Arch Wires | — | — |
| Dickerson Orthodontics | United States | Maker | D2 Appliance | — | — |
| HeiLongJiang Rainbow Technology Co., Ltd. | China | Maker | Orthodontic Wire | — | — |
| Matrix Health, Inc. | United States | Maker | ORTHODONTIC SPRING | — | — |
| MPL Manufacturing Inc. | United States | Maker | — | — | — |
| Smarter Alloys Inc | Canada | Maker | SmartArch | — | — |
| COHO Advanced Materials Tech. Co., Ltd. | Taiwan | Maker | "COHO" Orthodontic appliance and accessories | — | — |
| DANY BMT Co., Ltd. | South Korea | Maker | Orthodontic wire | — | — |
| Wire and Cable Specialties Inc | United States | Maker | Multiple - Industry Generic Names | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Orthodontics Springs and Wires | 23 | 2025 |
| 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 | 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 | 2 | 2010 |
| Sotera Health LLC | United States | Contract manufacturer | IP200 Craniofacial Onlay | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO IMPORT AND EXPORT LIMITED | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Jmu | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Super Elastic Nickel Titanium Arch Wire | — | — |
| 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 · +7 | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Adams Clasps · Archwire · Arrow Anchors · Arrow Clasps · +12 | — | — |
| 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 · +9 | — | — |
| 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 · +15 | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| Forestadent Usa | United States | Repacker / relabeler | WIRE | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Contract manufacturer | Duralloy Wire · Great Lakes Stainless Steel wire · Titanium Molybdenum | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Wire, Orthodontic | — | — |
| battech | United States | Repacker / relabeler | dental arch wire, Stainless Steel Kobyashi Wire, Braces Wire, Orthodontic Dental Ligature Wire | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Innova | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Orthodontic Wire | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | NITI WIRE · SS WIRE · TIBEND WIRE | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Copper NiTi Archwire · Advance NiTi Super-Elastic Reverse Curve Archwire · Advance Stainless Steel Archwire | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Professional Surgical Instruments Co., Inc. | United States | Manufacturer | Arch wires · Orthodontic Wires · Wires | — | — |
| O&S Dental Inc | United States | Manufacturer for export | — | — | — |
| SurgiPros LLC | United States | Repacker / relabeler | SURGIPROS | — | — |
| Mirabay Orthodontics Corporation | United States | Repacker / relabeler | Symmetry Archwires | — | — |
| Showcase Dental Lab LLC | United States | Contract manufacturer | Ortho Products | — | — |
| Progressive America Inc | United States | Repacker / relabeler | Medit Orthodontic Suite | — | — |
| 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 | — | — |
| Allure Ortho | United States | Repacker / relabeler | — | — | — |
| Modern Arch Corp. | United States | Repacker / relabeler | orthodontics | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 Nov 2011 | K112640 | HYPERELASTIC WIRE | Sybron Dental Specialties |
| 5 Oct 1994 | K943334 | HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT | Jay H. Geller |
| 18 May 1994 | K935638 | NITINOL, NITI | Highland Metals |
| 4 Feb 1994 | K935140 | DENTAURUM STEEL LIGATURE WIRES | Dentauraum, Inc. |
| 31 Jan 1994 | K935142 | DENTAURUM WIRES | Dentauraum, Inc. |
| 21 Jan 1994 | K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Flexmedics |
| 19 Nov 1993 | K933374 | NITI COIL SPRINGS | Highland Metals |
| 16 Nov 1993 | K933377 | STAINLESS STEEL ARCHES REPACKER RELABETER | Highland Metals |
| 12 Nov 1993 | K933380 | REVERSE SURVE NITI ARCH WIRE | Highland Metals |
| 12 Nov 1993 | K933379 | STAINLESS STEEL ARCHES | Highland Metals |
| 12 Nov 1993 | K933378 | REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER | Highland Metals |
| 12 Nov 1993 | K933376 | NITI ARCH WIRE ON A SPOOL | Highland Metals |
| 28 Jul 1993 | K931631 | COATED ORTHODONTIC DEVICES | Wonder Wire |
| 27 May 1993 | K930202 | TITAN SEPARATING SPRING | Ortho Spectrum, Inc. |
| 31 Mar 1993 | K924805 | ORTHODONTIC ARCH WIRE | Ultimate Wireforms, Inc. |
| 31 Mar 1993 | K923837 | DIMPLED MULTI MODULUS ARCH WIRE | Ultimate Wireforms, Inc. |
| 23 Dec 1992 | K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | Ultimate Wireforms, Inc. |
| 4 Dec 1992 | K923838 | THE ULTIMATE RCS ARCH WIRE | Ultimate Wireforms, Inc. |
| 4 Nov 1992 | K920905 | BIOFORCE WIRE | Gac Intl., Inc. |
| 15 Oct 1992 | K923839 | NITINOL GENTLE TOUCH COIL SPRING | Ultimate Wireforms, Inc. |
| 24 Aug 1992 | K920850 | GAC THUMB-SUCKING CONTROL APPLIANCE | Gac Intl., Inc. |
| 24 Nov 1986 | K863742 | FLEXMEDICS NITINOL ARCH WIRE | Flexmedics |
| 31 Oct 1985 | K852975 | INTERPORE 200 POROUS HYDROXYAPATITE | Inrterpore Intl. |
| 5 Jun 1985 | K851878 | A COMPANY BRASS SEPARATING RINGS | A Company, Inc. |
| 9 May 1985 | K851055 | SENTINOL -ORTHODONTIC ARCH WIRE | Gac Intl., Inc. |
| 3 Dec 1984 | K843171 | FILAFEX TM, ESTHETIC ORTHODONTIC WIRE | Berkley and Co. |
| 9 Nov 1984 | K843722 | ORTHODONTIC WIRE | Arthur L. Wool |
| 27 Jun 1984 | K841638 | ALINE ORTHODONTIC ARCHWIRE | A Company, Inc. |
| 24 Jan 1984 | K833788 | FILAFEX ESTHETIC ORTHODINIC WIRE | Berkley and Co. |
| 23 Sep 1981 | K812454 | PAC-AID | Albert J. Anthony, Dmd |
Official records: FDA product classification for DZC · 21 CFR 872.5410.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026