Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Metal Bracket
FDA device type “Bracket, Metal, Orthodontic”.
- Companies listing it
- 153112 makers
- Brands and models
- 1,409
- 510(k) clearances
- 1030 in five years
- FDA name
- Bracket, Metal, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list EJF
153 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| American Orthodontics | United States | Maker | Diastema · Empower 2 · Forever Gold · Forever Gold 24K · +12 | 44 | 2026 |
| LightForce Orthodontics, Inc | United States | Maker | LightBracket | 3 | 2023 |
| Cdb Corporation | United States | Maker | RELECTIONS | 9 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | Aria Brackets · Aria Expressions · BAND & BRACKET ASSEMBLY · Bionic · +52 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Begg Metal Bracket · Generations Brackets · Nu-Edge II Cobalt Chromium Twin bracket · Nu-Edge NX · +7 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | METAL BRACKETS · MIDI DIAGONALI · MINI DIAGONALI | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Ze Fang Technology Co., Ltd. | Taiwan | Maker | Classic Mini B.MBT18 (345H) · Classic Mini B.MBT18 LL1(W/O) · Classic Mini B.MBT18 LL2(W/O) · Classic Mini B.MBT18 LL3(W/H) · +362 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Ceramic Bracket/ · Metal V-slot Brackets/ · Orthodontic Metal Brackets/ · Self-Ligating Brackets/ | 1 | 2025 |
| EC Certification Service GmbH | Austria | Maker | Metal Triple Edge Button | 1 | 2025 |
| Celebrace | United States | Maker | Celebrace Custom Brackets | 1 | 2025 |
| Medartis AG | Switzerland | Maker | Titanium Arch Bar · TTS Tooth Splint · TTS-Titanium Trauma Splint | 6 | 2007 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Mediloy RPD | 4 | 2013 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic Metal Brackets | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | ZEUS Bracket, META Bracket | 3 | 2021 |
| Dentos, Inc. | South Korea | Maker | AA-18-11 · AA-18-12 · AA-18-13H · AA-18-16H · +71 | 2 | 2019 |
| G&H Wire Company | United States | Maker | AGILITY · AGILITY TWIN · Auralis · CANNON ELITE · +12 | 2 | 2008 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| World Bio Tech Co Ltd | South Korea | Maker | DELICATE Metal Brackets, SELPRO Metal Brackets | 2 | 2016 |
| Acme-Monaco Corp. | United States | Maker | MULTIPLE PRODUCTS | 2 | 1990 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| HT Co., Ltd. | South Korea | Maker | Cross-M · Cross-MD · Cross-MH · Cross-MW | 1 | 2011 |
| Rmo, Inc. | United States | Maker | FLI mini;FLI Twin;Integra;Mini-Taurus;Alexander;Synergy;Synergy fx;Alpine SL;Mini Low Profile;Altitude SL;Mesh Base | 1 | 1990 |
| World Class Technology Corporation | United States | Maker | APII Class 2 Corrector · BioMIM · H4 · Pitts21 · +1 | 1 | 2019 |
| ASO International Manila, Inc. | Philippines | Maker | Harmony H32 | 1 | 2021 |
| Gestenco International AB | Sweden | Maker | — | 1 | 2005 |
| Hespeler Orthodontics Ltd | Canada | Maker | AWH16RD · AWH16X22RECT · AWH17X22SPEED · AWH17X25RECT · +500 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | dinamique c bracket · dinamique m bracket · discovery bracket · discovery pearl · +15 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | chewable tablets · metal braces · metal orthodontic appliance · metal orthodontic bracket · +5 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Orthodontic Metal Brackets/Ceramic Bracket/Self-Ligating Brackets/Metal V-slot Brackets | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ADVANCED SERIES BRACKETS · BIOVERSATIL BRACKETS · CAPELOZZA BRACKETS · LINEA D2 BRACKETS · +5 | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Bracket, Metal, Orthodontic · Bracket, Metal, Orthodontic (All types of orthodontic Metal Bracket) · CERAMIC BRACKETS · METAL BRACKETS · +4 | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | eXceed | — | — |
| Aditek do Brasil SA | Brazil | Maker | BioClip · BioClip PI · BioMax · EasyClip · +5 | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | A104-21 Monoblock Mini with hook on 3,4,5 Slot 022 Edgewise Bracket; · A108-21 Monoblock Mini with hook on 3,4,5 Slot 022 Roth Bracket; · A116-21 Monoblock Mini with hook on 3,4,5 Slot 022 MBT Bracket; · A120-21 Monoblock Mini with hook on 3,4,5 Slot 022 MBT Self Ligating Bracket; · +18 | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | Dr. Unbong's M-P Tube(Molar Protraction Tube) · MAJESTY Tube · MAJESTY-SLM · Sensation M · +2 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | BT2 - BITURBO · HEXAGON · MICROFIT · SIA ORTHODONTIC MANUFACTURER · +4 | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Orthodontic Brackets | — | — |
| Innovative Material And Devices, Inc. | China | Maker | ActMIM Roth/McBeTr/Roth+ Interactive Self-Ligating Metal Brackets, High Torque/Low Torque,ProMIM IX Roth/McBe · Atua, Ophro, Mini Arch, Copolla, Smile, Omni Plus, ACE Plus, McBeTr/Roth/Edgewise, Standard/Mini Metal Twin Brackets · FOMIC Advanced Light Wires Passive Self-Ligating Metal Brackets · ProMIM Roth/McBeTr Standard Passive Self-Ligating Metal Brackets,ProMIM X, · +1 | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | ORTHODONTIC KIT | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | Eurodonto · Protect | — | — |
| Lohar Medical Company | Pakistan | Maker | EJF / BRACKET, METAL, ORTHODONTIC | — | — |
| Astar Orthodontics Inc | China | Maker | — | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | BRACKET, METAL, ORTHODONTIC | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodontic Bracket, Lingual Button | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | — | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Bracket | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Metal Ordinary Bracket | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | BRACKET, METAL, ORTHODONTIC · Metal partial framework (CoCr metal Partial , for Dental Restoration, Finished Product, Unused) | — | — |
| Guangzhou Four E's Scientific Co., Ltd. | China | Maker | Dental Metal Brackets | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic bracket · Orthodontic crimpable hooks · Orthodontic invisible bracket · Orthodontic lingual button · +1 | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Orthodontic Metal Bracket models: DO-I,DO-II,DO-III,DO-IV,CNS-I,CNS-II,CNS-III,CNS-IV | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Metal Bracket, Orthodontic Metal Bracket, Ceramic brackets | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental, OBRACE, O-EYES, Ceramic brackets | — | — |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manu | China | Maker | BRACKET · ELASTIC PLACER | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT ORTHODONTIC BRACKET - 1DERFUL ORTHODONTIC BRACKET | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | Palatal Expander | — | — |
| Sino Ortho Limited | China | Maker | braes, orthodontic | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | Orthomechanics · Smart | — | — |
| Zhejiang Headway Medical Equipment Co., Ltd. | China | Maker | Orthodontic Crimpable Hooks · Orthodontic Lingual Buttons · Orthodontic Lingual Sheaths · Orthodontic Metal Brackets · +1 | — | — |
| Fseven Dental Technology Zhuhai Co.,ltd | China | Maker | BRACKET,METAL,ORTHODONTIC · prosthesis orthodntic | — | — |
| Garnet Dentech | South Korea | Maker | Metal Bracket | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Bracket, Metal Orthodontic | — | — |
| United Dental Changzhou | China | Maker | Orthodontic metal Brackets, Orthodontic metal self ligating Brackets | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Metal Bracket | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | LeapBar Class II Malocclusion; Bite Corrector; LeapBar Class III Appliance; LeapBar Class III Corrector; · LeapBar Class III Malocclusion; Palatal Expander · Orthodontic Bracket; Lingual Button; LeapBar Class II Appliance; LeapBar Class II Corrector; | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | BRACKET | — | — |
| American Angle Ortho, LLC | United States | Maker | Pro-Master Metal Bracket, Alaska Metal Bracket, Compact-Passive Metal Bracket, Compact-Active Metal Bracket | — | — |
| Funing Meitedental Factory | China | Maker | Orthodontic Brackets, Lingual Buttons, Selfligate Brackets, Ceramic Brackets | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Dental Brackets;DTC;Orthodontics | — | — |
| Libral Traders Pvt Ltd | India | Maker | Orthodontic Bracket | — | — |
| Modern Orthodontics | India | Maker | At-Ease, Sapphire, Sapphire Plus, Micro LP · Sapphire, At-Ease, Sapphire Plus, Micro LP | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | orthodontic brackets/lingual button | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | BRACKET, METAL, ORTHODONTIC | — | — |
| 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 | — | — |
| Hansfive (Hangzhou) Dental Technology Co., Ltd. | China | Maker | Orthodontic Brackets | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Orthodontic metal brackets | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Dongguan Xinletian Dental Equipment Co., Ltd. | China | Maker | Orthodontic Bracket | — | — |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd | China | Maker | hangzhou 3B | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Orthodontic Metal Bracket | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Guangzhou Riton Biomaterial Co., LTD | China | Maker | Customised Orthodontic Bracket Set · Customized Lingual Orthodontic Bracket · eLock Buccal Bracket · eLock Lingual 2D Bracket · +2 | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Metal Bracket, Metal Self-Ligating Bracket, Invisible Bracket | — | — |
| Foo Tian Dental Laboratory | China | Maker | Orthodontic Appliance and customized clear aligners | — | — |
| F-Six Dental Technology Co.,limited | Hong Kong SAR China | Maker | prosthesis orthodntic | — | — |
| GZ Chuangqi Medical Tech Co., Ltd. | China | Maker | Inbracket, Customized Labial Self-ligating Bracket, Inbracket-B · Inbracket, Customized Lingual Bracket, Inbracket-L · Inbracket, Customized Lingual Self-ligating Bracket, Inbracket-LS · Inbracket, Customized Lingual Self-ligating Bracket, Inbracket-S | — | — |
| JINHUA GLAMB MEDICAL EQUIPMENT Co., Ltd. | China | Maker | Metal Brackets | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Progressive America Inc | United States | Maker | Medit Orthodontic Suite | — | — |
| PSM Medical GmbH | Germany | Maker | Crown Brackets · Econoline Brackets · Flair Brackets · Triamond Brackets | — | — |
| Yancheng Denrum Medical Apparatus Co Ltd | China | Maker | Orthodontic Brackets | — | — |
| Lorelli Technologies LLC | United States | Maker | InSmile Braces Orthodontic System | — | — |
| Ortho Attachyhook Supply LTD. | Canada | Maker | Attachyhook Bracket | — | — |
| Aegion Technologies Inc | United States | Maker | Ortavia Arch Wires | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| Dickerson Orthodontics | United States | Maker | D2 Appliance | — | — |
| MPL Manufacturing Inc. | United States | Maker | Metal Bracket | — | — |
| Ortho Traction Pads | United States | Maker | Traction Pad · Tractionpad | — | — |
| Shenzhen Bairunheng Technology Co., Ltd. | China | Maker | Orthodontic Brackets;Model:16159542 | — | — |
| Xemax Surgical Products, Inc. | United States | Maker | Cusp-Lok | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | — | — | — |
| Azure Microdynamics, Inc. | United States | Maker | VECS Palate Expander | — | — |
| BOCH Group LLC | United States | Maker | Orthodontic Self Ligating Brackets | — | — |
| DW LIngual Systems GmbH | Germany | Maker | WIN | — | — |
| Innobrace Orthodontics Pte Ltd | Singapore | Maker | EPSILON | — | — |
| Sunstar Trading International Limited | China | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Orthodontics Products | 23 | 2025 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | — | 32 | 2021 |
| Dexcowin Co., Ltd. | South Korea | Foreign exporter | Tiggle | 4 | 2017 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | Evolve Orthodontic Brackets | 2 | 2010 |
| Ortho-Cycle Co. | United States | Reprocessor | — | 1 | 1991 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL ORTHODONTIC BRACKET | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| Digital Dental Laboratories, Inc. DBA Orthodent | Canada | Manufacturer | Bracket 5-5 Inovation R · Bracket Inovation R · Bracket Inovation R Positioned · Brackets 6-6 Mini Twin | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Jmu | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Metal Bracket | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Bracket accessories; Crimpabal hooks;Crimpabal stopers , lingual buttons; Metal bracket; Orthodontic brackets · Self max-Selfligating Bracket System MBT slot 18 · Self max-Selfligating Bracket System MBT slot 22 · Self max-Selfligating Bracket System Roth slot 18 · +13 | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Bondable Tongue Spurs · Buttons · Cleats · Edgewise Brackets · +3 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Majestic · Max · Razor · Royal | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Orthodontic Bracket | — | — |
| Orthoworld, L.L.C. | United States | Repacker / relabeler | FASTBRACES® CLASSIC Metal LL/LR 1/2 · FASTBRACES® CLASSIC Metal LL/UR 6 · FASTBRACES® CLASSIC Metal LL3 · FASTBRACES® CLASSIC Metal LR3 · +35 | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Composite Direct Bond Button · Conlin · Horizon Twin · Micro Twin · +1 | — | — |
| Csy International LLC | United States | Repacker / relabeler | Beacon · Dorada · J&J Ortho · J&J Orthodontics · +5 | — | — |
| Forestadent Usa | United States | Repacker / relabeler | Alexander S · Aspire Ceramic · Aspire Plus · BioPassive · +19 | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Bracket, Metal, Orthodontic | — | — |
| battech | United States | Repacker / relabeler | dental brackets | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | ORTHODONTIC KIT | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Ghost · Halo · Integrity · Lux V-Slot · +4 | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | BRACKET, METAL ORTHODONTIC | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | GEM PLUS BRACKETS · LP GEM BRACKETS · STRATUS BRACKETS | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Precision Premium Series Brackets · Advance Precision Series Brackets | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix Crystal Clear · Phoenix Optimal · Value Line | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| O&S Dental Inc | United States | Manufacturer for export | Orthodontic Bands · Orthodontic Brackets | — | — |
| Oriental International Supplies Limited | Hong Kong SAR China | Foreign exporter | ELASTIC PLACER | — | — |
| Tangent Technologies LLC | United States | Contract manufacturer | Orthodontic Metal Brackets | — | — |
| Mirabay Orthodontics Corporation | United States | Repacker / relabeler | KLEOS BRACKETS AND BUCCAL TUBES | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Cx Orthodontic Supply | United States | Repacker / relabeler | CX Ortho Supply | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| DentOrtho LLC | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 14 Mar 2000 | K994357 | BITEM LOCK, MODELS SW006, SW012 | Thermoelastic Technologies, Inc. |
| 9 May 1994 | K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. |
| 28 Apr 1994 | K933501 | ALASTIK | Unitek Corp. |
| 22 Apr 1994 | K923372 | MEMORY WIRE | Althan, Inc. |
| 23 Mar 1994 | K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech |
| 4 Feb 1994 | K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. |
| 2 Feb 1994 | K936244 | REGENCY BRACKET | Mid-American Dental Specialties, Inc. |
| 1 Feb 1994 | K934881 | REFLECTIONS | Cdb Corporation |
| 31 Jan 1994 | K935122 | DENTAURUM METAL BRACKETS | Dentauraum, Inc. |
| 26 Jan 1994 | K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. |
| 26 Jan 1994 | K925028 | FORESTADENT ORTHODONTIC BANDS | Forestadent |
| 21 Jan 1994 | K930881 | CHANNEL-EDGE BRACKET SYSTEM | Dualtek, Inc. |
| 18 Jan 1994 | K933758 | REGENCY PLUS BRACKET | Mid-American Dental Specialties, Inc. |
| 20 Oct 1993 | K922806 | ORMCO SPORTSGUARD | Sybron Dental Specialties |
| 13 Sep 1993 | K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. |
| 13 Sep 1993 | K925012 | PLASTIC CHAIN | American Orthodontics |
| 13 Sep 1993 | K923218 | NITANIUM PALATAL EXPANDER | Ortho Organizers, Inc. |
| 8 Jul 1993 | K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Ortho Organizers, Inc. |
| 8 Jul 1993 | K930452 | SOLO TIES | Zulaf, Inc. |
| 27 May 1993 | K924971 | FORESTADENT BRACKETS | Forestadent Bernhard Forster GmbH |
| 5 May 1993 | K923405 | THE HERBST APPLIANCE | Sybron Dental Specialties |
| 31 Mar 1993 | K923440 | APEX DIRECT BONDED BRACKETS | Apex Orthodontics, Inc. |
| 2 Feb 1993 | K923709 | MEMORY WIRE | Wire Products |
| 3 Dec 1992 | K923261 | ORTHODONTIC METAL BRACKET | American Orthodontics |
| 30 Oct 1992 | K923432 | GERMAN MINI DYNALOCK | Unitek Corp. |
| 28 Sep 1992 | K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | Gac Intl., Inc. |
| 27 Aug 1992 | K923124 | GLENROE GOLDEN ORTHODONTIC BRACKET | Glenroe, LLC |
| 30 Jul 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corporation |
| 28 Jul 1992 | K920645 | ORTHODONTIC ELASTICS BANDS | Masel Industries, Inc. |
| 16 Dec 1991 | K914003 | MIDAS BRACKET | Gold'N Braces, Inc. |
| 27 Nov 1991 | K913913 | REFURBISHED ORTHODONTIC APPLIANCES | Ortho-Cycle Co. |
| 20 Nov 1991 | K914616 | KLEER(TM) ORTHODONTIC BRACKET | Sybron Dental Specialties |
| 8 Oct 1991 | K911231 | ORTHODONTIC WIRE | Masel Industries, Inc. |
| 13 Aug 1991 | K912171 | PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE | Jack James |
| 29 Mar 1991 | K910288 | NONSTAINING ALASTIKS | Unitek Corp. |
| 12 Mar 1991 | K903498 | RETAINER, SCREW EXPANSION ORTHODONTIC | Masel Industries, Inc. |
| 7 Dec 1990 | K902809 | BRACKET, METAL, ORTHODOTNIC | Masel Industries, Inc. |
| 9 Nov 1990 | K904092 | LANCER ORIGINAL, SIERRA, GENERAL PURPOSE | Lancer Orthodontics, Inc. |
| 7 Nov 1990 | K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT | Lancer Orthodontics, Inc. |
| 5 Nov 1990 | K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO | Lancer Orthodontics, Inc. |
| 2 Nov 1990 | K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE | Lancer Orthodontics, Inc. |
| 2 Nov 1990 | K904089 | PERMA MESH | Lancer Orthodontics, Inc. |
| 5 Sep 1990 | K903214 | OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS | Medical Fittings, Inc. |
| 5 Sep 1990 | K902844 | NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN | Progressive Dental Supply |
| 13 Aug 1990 | K902390 | AURA CERAMIC DENTAL APPLIANCE | Progressive Technology, Inc. |
| 13 Aug 1990 | K901896 | ENDOMETRIAL SAMPLER | Kirwan Surgical Products, Inc. |
| 13 Aug 1990 | K900678 | THE MYOLOC SYSTEM | Winder Research, Inc. |
| 6 Aug 1990 | K902064 | MODIFIED UNI-STICK PLASTIC LIGATURE | American Orthodontics |
| 3 Aug 1990 | K902050 | BIOLASTIC SUPER ELASTIC ARCHES | Rmo, Inc. |
| 2 Aug 1990 | K900471 | FIBERBRAID(TM) BONDED RETAINER | Uthoff Dental Mfg. |
| 30 Jul 1990 | K901957 | MUSTANG, C.A.T. | Lancer Orthodontics, Inc. |
| 1 Jun 1990 | K900488 | MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE | American Orthodontics |
| 22 May 1990 | K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | Midwest Orthodontic Mfg. |
| 25 Apr 1990 | K901024 | STAINLESS STEEL DENTAL WIRES AND CLASPS | Ivoclar North America, Inc. |
| 10 Apr 1990 | K900578 | SPORTS PACK ELASTICS | Lancer Orthodontics, Inc. |
| 9 Apr 1990 | K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | Acme-Monaco Corp. |
| 2 Apr 1990 | K900184 | LINGUAL SHEATH | Sybron Dental Specialties |
| 29 Jan 1990 | K895483 | ACME COATED ORTHODONTIC ARCHWIRE | Acme-Monaco Corp. |
| 16 Oct 1989 | K891331 | UNI-STICK PLASTIC LIGATURES | American Orthodontics |
| 12 Oct 1989 | K893482 | KORN MANDIBULAR ADVANCER | American Orthodontics |
| 15 Sep 1989 | K894781 | OPTIFLEX | Sybron Dental Specialties |
| 15 Sep 1989 | K894358 | LUMINA ORTHODONTIC BRACKET | Sybron Dental Specialties |
| 23 Aug 1989 | K893655 | KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK | American Orthodontics |
| 14 Jul 1989 | K893555 | X-RING AND SPEED STIX PLASTIC LIGATURES | American Orthodontics |
| 14 Jul 1989 | K893550 | PLASTIC FORCE MODULE | American Orthodontics |
| 14 Jul 1989 | K893484 | MULTIPHASE ORTHODONTIC WIRE | American Orthodontics |
| 14 Jul 1989 | K893483 | BONDABLE RETAINER AND SPACE MAINTAINER | American Orthodontics |
| 14 Jul 1989 | K891982 | J1 ATTACHMENT (ORTHODONTIC APPLIANCE) | T.M.K. Dental Products |
| 23 Jun 1989 | K893654 | MEMORY CHAIN | American Orthodontics |
| 23 Jun 1989 | K893549 | X-RING SEPARATORS | American Orthodontics |
| 23 Jun 1989 | K893542 | DIASTEMA CLOSING KIT | American Orthodontics |
| 16 Jun 1989 | K892419 | NPG 2 BASE METAL ALLOY | Aalba Dent, Inc. |
| 12 Jun 1989 | K892704 | GEM II ORTHODONTIC BRACKET | Sybron Dental Specialties |
| 11 May 1989 | K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES | American Orthodontics |
| 2 May 1989 | K891599 | FILAFLEX ORTHODONTIC WIRE | American Orthodontics |
| 1 May 1989 | K890536 | JASPER JUMPER KIT | American Orthodontics |
| 17 Apr 1989 | K890656 | LIP BUMPER | American Orthodontics |
| 14 Apr 1989 | K891484 | ORTHODONTIC WRAP-AROUND HAWLEY RETAINER | American Orthodontics |
| 7 Apr 1989 | K891592 | ORTHODONTIC ARCH AND SURGICAL HOOKS | American Orthodontics |
| 17 Mar 1989 | K890581 | THE CLARK LIP SHIELD | American Orthodontics |
| 13 Mar 1989 | K890145 | 20/20 ORTHODONTIC CERAMIC BRACKET | American Orthodontics |
| 9 Mar 1989 | K890529 | ALASTIGARD | Unitek Corp. |
| 10 Jan 1989 | K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Flexmedics |
| 14 Nov 1988 | K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE | Flexmedics |
| 1 Jun 1988 | K881789 | MINILINE BRACKET | Alexotek Co. |
| 18 May 1988 | K874396 | OCO PREPARATIONS | Williams Importing Company, Inc. |
| 12 Apr 1988 | K881274 | CENTER BEND ARCH WIRES | Flexmedics |
| 12 Apr 1988 | K881233 | STRAIGHT LENGTH ARCH WIRES | Flexmedics |
| 11 Apr 1988 | K880882 | REVERSE CURVE ARCHWIRE | Flexmedics |
| 7 Apr 1988 | K881163 | RECTANGULAR NITINOL ARCH WIRE | Flexmedics |
| 29 Dec 1987 | K874226 | STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET | Advanced Orthodontics Systems, Inc. |
| 5 Oct 1987 | K873649 | FLEX GOLD | Flexmedics |
| 19 Feb 1987 | K870536 | GEM ORTHODONTIC BRACKET | Sybron Dental Specialties |
| 20 Aug 1985 | K852179 | CERAMIC ORTHODONIT APPLIANCE | Gac Intl., Inc. |
| 31 Jul 1985 | K852800 | A-COMPANY SELF-LIGATING APPLIANCE | A Company, Inc. |
| 23 Nov 1984 | K844067 | VANISH ORTHODONTIC BRACKET | A Company, Inc. |
| 27 Sep 1984 | K843143 | STABILIZING RETAINER | Dental Advancements, Inc. |
| 3 Feb 1984 | K834272 | ALEXOLOK BRACKET | Alexotek Co. |
| 21 Sep 1981 | K812300 | LINGUAL BRACKET | American Ormco |
| 14 Jan 1981 | K803316 | ORTHODONTIC BRACKET | Orec Corp. |
| 13 Aug 1980 | K801809 | ORTHODONTIC BRACKET/SPEED/HANSON SPEED | Strite Industries , Ltd. |
| 15 Mar 1978 | K780170 | ORTHODONTIC BRACKET PADS | Rocky Mountain Orthodontics, Inc. |
| 30 Sep 1977 | K771774 | NEW BASE FOR ORTHODONTIC APPLIANCES | Gac Intl., Inc. |
Official records: FDA product classification for EJF · 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