Retainers, expanders & headgear: manufacturers and brands
195 companies make or specify orthodontic appliances among the 232 that list one with FDA, under 1,075 brand and model names. FDA has issued 57 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Orthodontic appliance 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 |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | REF04 ClearCorrect System Retainer | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Essix (Sports) Mouthguard · Essix A+ · Essix ACE · Essix C+ · +5 | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | Glidewell TuffSplint Appliance Resin | 56 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | 3D Printing Material Splint | 16 | 2026 |
| Voco GmbH | Germany | Maker | V-Print ortho · Curvy · V-Print SG | 117 | 2026 |
| Align Technology, Inc. | United States | Maker | Invisalign Retainer · lnvisalign Specifix Attachment System · lnvisalign Specifix Attachment System (include Engagement Features) · Vivera 3D retainer · +1 | 16 | 2026 |
| SprintRay Inc. | United States | Maker | Motto Day 1 Tray 1 · NightGuard Firm · NightGuard Firm 2 (Midnight Purple) · NightGuard Flex · +3 | 8 | 2026 |
| GC America Inc. | United States | Maker | everStickORTHO | 137 | 2026 |
| Hiossen Inc. | United States | Maker | Tooth Positioner | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | ACCO Expander · Acrylic Bonded RPE · Activators · Adaptor · +66 | 203 | 2026 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | Splint Soft Resin SS01; Splint Hard Resin SH01 | 6 | 2026 |
| Graphy, Inc. | South Korea | Maker | Tera Tainer (Model : TA-83) | 6 | 2025 |
| Deltamed GmbH | Germany | Maker | P pro Splint | 6 | 2024 |
| LuxCreo Inc. | United States | Maker | LuxCreo Clear Retainer System · LuxCreo Dental Clear Aligner Resin · LuxCreo Dental Night Guard Resin | 4 | 2026 |
| American Orthodontics | United States | Maker | EAGLEWEAR; · Protraction Face Mask · Alexander Lip Bumper · Cantilever Bar Offset · +31 | 44 | 2026 |
| Park Dental Research Corp | United States | Maker | Volo DigiLine23 | 8 | 2026 |
| Vivos Therapeutics, Inc. | United States | Maker | Facialblocks · V-Starter Kids; V-Starter PreTeen; Vivos Grow (VG); Vivos Guide System; Vivos Way (VW) · V-Starter Kids · V-Starter PreTeen · +3 | 3 | 2024 |
| Guangzhou Heygears IMC., Inc. | China | Maker | UltraPrint Hard Splint UV | 3 | 2026 |
| Good Sleep Co Pte Ltd | Singapore | Maker | Hushd Pro Guard · Splint | 3 | 2025 |
| Somnomed, Inc. | United States | Maker | Morning Repositioner | 11 | 2026 |
| Vertex-Dental B.V. | Netherlands | Maker | Ceramill Ortho Flex · Ceramill Ortho Rigid · Dental LT Clear · E-Guard · +3 | 7 | 2024 |
| Pac-Dent Inc. | United States | Maker | Rodin 3D Resin Clear Bite Spl | 5 | 2022 |
| Smylio | United States | Maker | FXBright Retainers · FXClear Retainers · FXTetra Bright Retainers · Smylio Retainer 1 | 4 | 2026 |
| Keystone Industries | United States | Maker | KeyPrint KeySplint Hard · KeySplint Soft · Proform Splint and ProSplint · Proform Super Clear Retainer | 2 | 2025 |
| Detax GmbH | Germany | Maker | FREEPRINT splintmaster flex 1000g · FREEPRINT splintmaster taff 1000g · Primeprint Guide 2 · Primeprint Splint SF 1000g · +10 | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Modern Dental Laboratory Co., Ltd. | China | Maker | Basic retainer · Bleaching retainer · Ecodont retainer · Finishing retainer · +2 | 2 | 2024 |
| Formlabs Inc. | United States | Maker | Dental LT Clear V2 Resin · Dental LT Comfort Resin | 2 | 2026 |
| Zhejiang Yinchili Medical Technology Co.,Ltd | China | Maker | REF04 ClearCorrect System Retainer, Clear Retainer (YCL-A-R, YCL-C-R) | 2 | 2023 |
| KJ Meditech Co., Ltd. | South Korea | Maker | KJ MASK | 13 | 2022 |
| The Argen Corporation | United States | Maker | Argen Clear Retainer · Argen Flex | 11 | 2024 |
| Ortho Organizers, Inc. | United States | Maker | Cervical Neck Pads · ClassOne Facemask · ClassOne Safety Release Modules · Extraoral Facebows · +19 | 8 | 2025 |
| Dreve Dentamid GmbH | Germany | Maker | BioBleach hart/soft · Biolon · Drufolen H · Drufosoft · +4 | 6 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | KBE II-10 · KBE II-12 · KBE II-6 · KBE II-8 · +72 | 5 | 2023 |
| Tp Orthodontics, Inc. | United States | Maker | Custom retainer · Custom tooth positioner · Pre-Finisher · Pre-finisher appliance with seating spring · +8 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | LEONE EXPANDERS · Mandibular advancers · Thermoplastic material · Orthodontic headgear, facemask/bow | 4 | 2025 |
| Myofunctional Research Co. Usa Inc. | United States | Maker | Bruxogard · Myobrace · Myoretainr · Myotalea · +5 | 3 | 2026 |
| NuSmile, Ltd. | United States | Maker | Chairside Space Maintainer | 2 | 2026 |
| Microware Precision Co., Ltd. | Taiwan | Maker | QS Screw | 2 | 2022 |
| Wuxi EA Medical Instruments Technologies Limited | China | Maker | Retainer | 2 | 2023 |
| Riton 3D Technology Co., Ltd | China | Maker | Splint Model HS1-T · Splint Model SS1-T | 1 | 2024 |
| Kids-E-Dental LLP | India | Maker | e-space maintainer | 1 | 2024 |
| Dongguan Yiyao Science & Technology Development Co., Ltd. | China | Maker | Dental Orthodontic Retainer instruments (Positioner, Tooth, Preformed, Preformed tooth positione, Braces Orthodont, · orthodont dental, dental orthodont, orthodontic tools dental · Orthodontics, Dental Orthodontic Brackets, Dental Orthodontics, Dental Orthodontic Retainer instruments, | 1 | 2025 |
| MK Meditech | South Korea | Maker | ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ | 1 | 2021 |
| Id Korea Co., Ltd. | South Korea | Maker | ID Light Cure System | 1 | 2025 |
| ODS Co., Ltd. | South Korea | Maker | ODS Clear Resin - Retainer | 1 | 2025 |
| Archform Inc. | United States | Maker | Archform Retainer | 1 | 2021 |
| Beame Medical Technology (Shenzhen) Limited | China | Maker | Retainer | 1 | 2026 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | Tray and Temporary Splint | 11 | 1996 |
| Whip Mix Corporation | United States | Maker | VeriFIT Splint | 8 | 2016 |
| Ortho Kinetics Corp. | United States | Maker | AD Protraction Facemask · Facebow · Locking Facebow · NewGear Releasable Headgear · +2 | 7 | 1998 |
| Micerium S.P.A. | Italy | Maker | Amcop Bioactivator · ELASTOOSAS | 6 | 2011 |
| Airway Management, Inc. | United States | Maker | AM Aligner | 5 | 2018 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Mediloy RPD | 4 | 2013 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic Expansion Screw · Orthodontic Retainer · OrthoEasy Pal · OrthoEasy Pal Long Neck · +1 | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| OSTEONIC Co., Ltd. | South Korea | Maker | POWER SYSTEM · T4A.10010 · T4A.10010F · T4A.10020 · +37 | 3 | 2021 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho | 3 | 2021 |
| G&H Wire Company | United States | Maker | N/A · NEOsmile | 2 | 2008 |
| Suncoast Dental Corp. | United States | Maker | Positioner Set 1, 2 · Spacer Set 1, 2, 3, 4 | 2 | 1981 |
| pro3dure medical GmbH | Germany | Maker | ACRY Print RU-005 Guide · dima Print Splint clear · FLOW Hard Splint · GR-10 guide · +11 | 2 | 2021 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Rmo, Inc. | United States | Maker | Orthopedic Face Mask · Spring Gear/Safety Headgear; Facebow Penta-form; · Quad Helix, Multi-Action Appliance, Palatal Appliance, Adapter · Rapid palatal expander · +4 | 1 | 1990 |
| Sawbros Industries Pvt., Ltd. | India | Maker | Retainer Wire · Reverse Pull Adjustable Facemask | 1 | 2017 |
| Apnomed, Inc. | United States | Maker | ApnoMed TEEN · ApnoTx Orthodontic Appliance · DAMES Distraction Assisted Mandibular Expander · MAPE Micro-Implant Assisted Protractor Expander | 1 | 2018 |
| Biotech Dental Smilers, SAS | France | Maker | FROGGYMOUTH · MYOSIMPLE · SMILERS | 1 | 2021 |
| ASO International Manila, Inc. | Philippines | Maker | — | 1 | 2021 |
| Royal Dental Laboratory | China | Maker | Preformed Tooth Positioner | 1 | 2020 |
| Fernando Morales Garfias | Mexico | Maker | AD Protraction Facemask · Asian Profile AD Protraction Facemask · MORALES PROTRACTION FACEMASK | 1 | 2003 |
| Kwang Myung Daicom, Inc. | South Korea | Maker | Headgear | 1 | 2011 |
| Osung Mnd Co Ltd | South Korea | Maker | Bone tack (BTKIT) | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | amda Advanced Molar Distalization Appliance · Expansion screw for progenia activator acc. to Weise · Expansion screw for split activator · Expansion screw key large · +40 | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Face mask · Multi-Adjustable Face Mask · Pedo reverse pull facemask · Activator · +119 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | ligature tie gun · Orthodontic accessories | — | — |
| Digital Dental Laboratories, Inc. DBA Orthodent | Canada | Maker | Bihelix - Removable · Bite Plate with 2 Adams Clasps · Bite Plate with 4 Ball Clasps · Bowbeer Appliance · +56 | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | aligner chewies | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Positioner | — | — |
| Shanghai Maxflex Medical Technology Co., Ltd. | China | Maker | Thermoforming sheet: D-LMEA-370-F120-130-H D-LMEA-460-F120-100-H D-LMEA-550-F120-200-H D-LMEA-370-F125-130-H · Thermoforming sheet: D-LMEA-460-F125-100-H D-LMEA-550-F125-200-H D-LMEA-550-F125-060-E · Thermoforming sheet: M-EC-100-F120-050-C M-EC-100-F125-100-N M-EC-100-F125-076-N M-EC-100-F125-063-N · Thermoforming sheet: M-EC-100-F120-050-E M-EC-100-F120-063-E M-EC-100-F120-040-C · +72 | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ICERAM CLEAR DISTALIZER · ORTHOMETRIC PRO ALIGNER X | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental splint | — | — |
| Lacigrus International | Pakistan | Maker | POSITIONER, TOOTH, PREFORMED | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Dental splint | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | ORTHODONTIC RETRACTION SCREWS · Retainer, Screw Expansion, Orthodontic · Retainer, Screw Expansion, Orthodontic (All types of Orthodontic Retainer and Expansion Screw) · XIHUBIOM · +2 | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Adaptable Class III Mask · Great Lakes Face Cribs · Nola Head gear · Biocryl Form-X · +9 | — | — |
| Aditek do Brasil SA | Brazil | Maker | Memoflex Copolyester; Memoflex PETG; Memoflex TPU | — | — |
| Solventum US LLC | United States | Maker | Orthodontic Expansion Screws · 3M Unitek · Friction-Stop Adjustage Facebow · Level Anchorage Facebow · +4 | — | — |
| Surgicrafts | Pakistan | Maker | DYJ / RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | LEONARDO PALATAL EXPANDER · SIA ORTHODONTIC MANUFACTURER · SMART CLICK · XP PALATAL EXPANDER · +2 | — | — |
| Vedia Solutions, Division of Laxmi Dental Limited | India | Maker | Taglus Aligner Removal Tool · Taglus Aligner Resin · Taglus Denture Resin · Taglus Flexi Denture Resin · +15 | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Preformed Tooth Positioner | — | — |
| Nadir & Co. | Pakistan | Maker | Bracket Positioner | — | — |
| Daddy D Pro | Pakistan | Maker | POSITIVE POSITIONER | — | — |
| Mount Blonck Trading | Pakistan | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Ortho Dental Lab, LLC | United States | Maker | SmileSet Night Guards · SmileSet Retainers | — | — |
| LM-Instruments Oy | Finland | Maker | LM-Activator · LM-Activator2 · LM-Dental · LM-Trainer | — | — |
| one day dental partner | South Korea | Maker | kage RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Retainer, Screw Expansion Orthodontic · Maintainer, Space Preformed, Orthodontic · Positioner Tooth Preformed | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | PriZma 3D Bio Splint · PriZma 3D Bio Splint Soft | — | — |
| Xplora USA LLC | United States | Maker | Six Month Smiles | — | — |
| Laboratorios Dentales de Zona Franca, S.A. | Costa Rica | Maker | Comfort 3D Bite Splint · Thermoforming Nightguard/Mouthguard/Bleaching Tray | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Retainer, Screw Expansion, Orthodontic | — | — |
| Candid Care Co. | United States | Maker | Candid Care Retainer · Candid Care Retainer Kit FGS-0003 · FGS-0003 PermaForm Retainer · FGS-2003 PermaForm Retainer Glidewell · +2 | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | BONE TAC · ORTHODONTIC SCREW | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Hawley Retainer · Retainer · CUSTOMIZED Retainer · DENTAL NIGHT GUARD | — | — |
| Suzhou laixin 3D Technology Co.,Ltd | China | Maker | NightGuard Resin (NightGuard, NightGuard Hard, NightGuard Soft) · Splint Resin (Splint, Splint Flex, Splint Flexi, Splint Hard, Splint Soft, DentalGuard, Dental Clear) | — | — |
| Scheu-Dental GmbH | Germany | Maker | Herbst · IST Appliance · Orthodontic Retainer · Telescopes · +11 | — | — |
| dentona AG | Germany | Maker | dentona flexisplint · dentona vivapink · dentona vivatemp · optimill memopink · +7 | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic retainer screw expansion · Orthodontic universal lingual retainers | — | — |
| Huizhou Gold Rose Technology Co.,Ltd | China | Maker | — | — | — |
| Richbolt Enterprises | Pakistan | Maker | RICHBOLT ENTERPRISES | — | — |
| Forest-One Co., Ltd. | Japan | Maker | T1 Initial · T1-LH · T1-LS · T1-MH · +11 | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Retainer, Screw Expansion, Orthodontic, Expansion Screw | — | — |
| Win Wings Corp. | Pakistan | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Aurum Group Ltd. | Canada | Maker | ORTHODONTIC APPLIANCE · TEETH POSITIONER | — | — |
| Sino Ortho Limited | China | Maker | lingual retainer, dental screw | — | — |
| HyperCert Limited | United States | Maker | Basic retainer · Bleaching retainer · Ecodont retainer · Finishing retainer · +2 | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | Preformed NiTi Retainer | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Retainer, Screw Expansion, Orthodontic | — | — |
| J C India | India | Maker | Rainbow preformed space maintainer | — | — |
| PHS Do Brasil LTDA | Brazil | Maker | POTENZA STAMPO EVA | — | — |
| United Dental Changzhou | China | Maker | Orthodontic Expansion Screws | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | RETAINER, MOUTHGUARD, BITEGUARD | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Screw Expansion; Orthodontic Expansion Screws; Orthodontic Appliance | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | RETAINER · SCREW EXPANSION | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Thermoforming Material (Hard Crystal, PP Plate, Soft Opaque, Bicolor, Black, Blue, Green, Pink or White) | — | — |
| Funing Meitedental Factory | China | Maker | Link Pins with drill, Titanium screw post · Stainless Steel Expansion Screw | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Expansion Screw;DTC;Orthodontics | — | — |
| Hexa Ceram Co., Ltd. | Thailand | Maker | PRE Rapid Palatal Expander | — | — |
| Libral Traders Pvt Ltd | India | Maker | Buttons, Orthodontic Appliances · MAINTAINER, SPACE PREFORMED, ORTHODONTIC | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC · MAINTAINER, SPACE PREFORMED, ORTHODONTIC · POSITIONER, TOOTH, PREFORMED | — | — |
| Shenzhen Baotonghui Industrial Co.,Ltd | China | Maker | Orthodontic accessories | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| Burbank Dental Lab | United States | Maker | — | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Nam A Dental Medicine Company Limited | Vietnam | Maker | All Ceramic Prosthesis · Implant-Supported Prosthesis · Porcelain-Fused-to-Metal Prosthesis | — | — |
| Smilden Biotechnology CO., Ltd. | Taiwan | Maker | Retainer | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | THERMOFORMING SHEETS FOR ALLIGNERS , ACETATE SHEETS | — | — |
| Erkodent Erich Kopp GmbH | Germany | Maker | Erkodur · Erkoflex · Erkolen · Erkolign · +3 | — | — |
| SMD Dental Laboratory | South Korea | Maker | orthodontic retainer | — | — |
| Dongguan Xinletian Dental Equipment Co., Ltd. | China | Maker | Customized Orthodontic Appliance, Screw Expander, Temporary Anchorage Device | — | — |
| KTJ Medical Technology Co.,Ltd. | China | Maker | Retainer, Screw Expansion, Orthodontic | — | — |
| Ningbo Sezen Technology Co., Ltd. | China | Maker | LuxCreo Clear Retainer System · LuxCreo Dental Clear Aligner Resin · LuxCreo Dental Night Guard Resin | — | — |
| Proto3000 Inc. | Canada | Maker | Vertex-Dental B.V. | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Alta Smiles, Inc | United States | Maker | Retain | — | — |
| Hantech Medical Device Co., Ltd. | China | Maker | Dental Foil · Mouthguard | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Orthodontic Expansion Screw | — | — |
| Zhejiang Longmed Medical Technology Co., Ltd. | China | Maker | Anti-snoring Braces · Lip Trainer · Mouth Guard, Lubyd · Preformed Tooth Positioner · +1 | — | — |
| Dantech Digital Dental Solutions Private Limited | India | Maker | Orthodontic Retainer | — | — |
| EOCA MD Pty Limited | Australia | Maker | Munchies | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | orthguide | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Shanghai Coherz Technologies Co., Ltd. | China | Maker | MOLEKUR Bright T,MOLEKUR Pro S lite, MOLEKUR One S, MOLEKUR One S+, MOLEKUR One H, MOLEKUR Nova, · MOLEKUR Express, MOLEKUR One, MOLEKUR Pro Eco, MOLEKUR Pro S, MOLEKUR Pro S+, MOLEKUR Pro Max, MOLEKUR Pro Max+, · MOLEKUR Template E, MOLEKUR Template U, MOLEKUR Pro Neo | — | — |
| Shanghai dental labs INC. | China | Maker | Orthodontic appliance and accessories | — | — |
| Eptamed srl | Italy | Maker | Equilibratori dentali · Freedom · Freedom Deep | — | — |
| JamesB Dental Studio | United States | Maker | JBDS | — | — |
| Jin Hsiang Enterprise Co., Ltd. | Taiwan | Maker | — | — | — |
| Ricomed LLC | United States | Maker | RICOmed Expansion Screws | — | — |
| Veden Dental Labs Inc | China | Maker | NTl Splint,Essix Retainer; Bleaching Tray; Night Guard; Sports Guard; Study Model; TPA retainer; Begg Retainer; · Palatel Expander; Quad Helix · Spring Hawley; Spring Appliance; Hawley Retainer; Space Maintainer; Nannce Appliance; Lingual Retainer; Thumb Crib; | — | — |
| Aegis Star Dental Technologies, Inc | United States | Maker | KKE- Keles Keyless Expander Kit · KKE- Keles Keyless Expander, | — | — |
| Anhui Chuangnuo Medical equipment Co., LTD | China | Maker | Maintainer, Space Preformed, Orthodontic | — | — |
| Chewly Pty. Ltd. | Australia | Maker | iChew | — | — |
| Gunmed Technik AG | Switzerland | Maker | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | — | — |
| HUBEI YJT INTELLIGENT TECHNOLOGY GROUP CO., LTD. (formerly k | China | Maker | Dental Orthodontic Retainer instruments Model:YT-01,YT-02,YT-03,YT-04,YT-05,YT-06 | — | — |
| Hype Align Clear Orthodontics, Limitada | Costa Rica | Maker | Hype Align | — | — |
| KTJ Dental Lab Inc. | United States | Maker | RETAINER,SCREW EXPANSION, ORTHODONTIC | — | — |
| Shenzhen Bairunheng Technology Co., Ltd. | China | Maker | Orthodontic Brackets;Model:16159542 | — | — |
| Sweetguard Inc | United States | Maker | Sweetguards Dental Retainer | — | — |
| Thanh Dental Laboratory | Vietnam | Maker | Thanh Dental Lab Dental Restorations | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | — | — | — |
| Angelalign Manufacturing Corp. | United States | Maker | — | — | — |
| Aurum Classic Ltd. | Canada | Maker | Classic retainer | — | — |
| Bright Dental Lab | China | Maker | Orthodontic Appliance, Screw Appliance | — | — |
| Dr Douglas J Shilliday Inc | United States | Maker | Shilliday Swivel Key | — | — |
| DTS Digital Dental Lab | China | Maker | — | — | — |
| Jumar Corporation | United States | Maker | Aqualizer Mouthpiece | — | — |
| LEWA-DENTAL Feinmechanik GMBH & CO. KG | Germany | Maker | Lewa-Dental Expansion Screws | — | — |
| Moses | United States | Maker | Unplastic Retainer | — | — |
| NACS, Inc | United States | Maker | Clear Liner | — | — |
| proNet, A Desco Industries Inc. Brand | United States | Maker | — | — | — |
| SCHEU-DENTAL custom-made GmbH | Germany | Maker | MEMOTAIN®, MEMOTAIN® Peek 3D | — | — |
| Smilecad | South Korea | Maker | NT-TAINER | — | — |
| Taurus Engineering and Manufacturing, Inc. | United States | Maker | MULTI ADJUSTABLE FACE MASK | — | — |
| Tiger Dental GmbH | Austria | Maker | PowerScrew | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| DMG Digital Enterprises SE | Germany | Maker | — | — | — |
| DongGuan Gooodol Mould & Product CO.,LTD | China | Maker | — | — | — |
| Edental Lab Co., Ltd | China | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Palaxa Precision LLC | United States | Maker | — | — | — |
| Uniontech, SRL | Italy | Maker | — | — | — |
| Kulzer, LLC | United States | Contract manufacturer | Dima Print Splint Clear | 37 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | American Flag Class III Adjustable Facemask · Flames Class III Adjustable Facemask · Hawaiian Print Class III Adjustable Facemask · Leopard Print Class III Adjustable Facemask · +5 | 23 | 2025 |
| Imagine Milling Technologies, LLC | United States | Contract manufacturer | Dental LT Clear; E-Guard; NextDent Ortho Clear; NextDent Ortho Clear E-Guard; NextDent Ortho Rigid | 4 | 2026 |
| Amann Girrbach AG | Austria | Foreign exporter | NextDent Ortho Flex | 3 | 2026 |
| Dental Manufacturing S.p.A. | Italy | Foreign exporter | ACRY PRINT 3D RU-005 GUIDE | 1 | 2026 |
| Sleepcare, LLC | United States | Repacker / relabeler | Rise and Bite | 1 | 2026 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM · ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Relining | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Forward Pull Headgear · SHEETS FOR TRAYS | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | — | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Denture resin | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Dentaurum Expansion Screw · Forestadent Expansion Screws · H-Screw · Leone Expansion Screws · +1 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Expand-Stick · Infinity Expander 7mm · Infinity Expander 9mm · Infinity Mini Expander · +4 | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Sport Mouthguard | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics · J&J ORTHODONTICS | — | — |
| Forestadent Usa | United States | Repacker / relabeler | RETAINER · SCREW EXPANSION | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Retainer, Screw Expansion, Orthodontic · POSITIONER, TOOTH, PREFORMED | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | — | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Retainer, Mouthguard, Bite Guard | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | Munchies Firm Refill Pack · Munchies Gentle Refill Pack · Munchies Maxx Refill Pack · Munchies Starter Pack · +1 | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Screws | — | — |
| Guangzhou OO Medical Scientific Limited | China | Foreign exporter | OO Dental, Retainer, Screw Expansion | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Space Maintainer | — | — |
| DigiSmiles Lab | United States | Repacker / relabeler | Retainer Screw Expansion Orthodontic | — | — |
| GLO Science, Inc. | United States | Contract manufacturer | Six Month Smiles Retainer | — | — |
| Primotec LLC | United States | Repacker / relabeler | CLEAR FLEX · primoflex CLEAR | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer | — | — |
| Hongkong Loyal Beauty Technology Limited | Hong Kong SAR China | Foreign exporter | POSITIONER, TOOTH, PREFORMED | — | — |
| KTJ Dental Lab Company Limited | Hong Kong SAR China | Private-label distributor | RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Nuvola World S.R.L. | Italy | Foreign exporter | FREEDOM · Freedom Deep | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | ORTHODENTALUSA CORP | — | — |
| ATFC Limited | Canada | Foreign exporter | Amcop Bioactivator; ELASTOOSAS · preformed - FROGGYMOUTH | — | — |
| Ezcad Dental Lab | United States | Repacker / relabeler | Space Maintainer | — | — |
| Orthodontic Supply & Equipment Co., Inc. | United States | Repacker / relabeler | Scandee Dental Retractors · Ultimate Ball Retainer Clasps | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | 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 appliances 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 Screw Expansion RetainerDYJ | 1 | 872.5410 | 94 | 5 |
| Preformed Tooth PositionerKMY | 1 | 872.5525 | 84 | 12 |
| Orthodontic Space Preformed MaintainerDYT | 1 | 872.5525 | 60 | 4 |
| Orthodontic Extraoral HeadgearDZB | 2 | 872.5500 | 15 | 36 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Jun 2021 | K202855 | Orthodontic Facemask | Ita.O Italian Orthodontic System S.R.L. | DZB Orthodontic Extraoral Headgear |
| 28 Aug 2017 | K162543 | Reverse Pull Adjustable Facemask | Sawbros Industries Pvt., Ltd. | DZB Orthodontic Extraoral Headgear |
| 3 Oct 2011 | K111169 | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF | Kwang Myung Daicom, Inc. | DZB Orthodontic Extraoral Headgear |
| 9 Jun 2011 | K103019 | KJ MASK | KJ Meditech Co., Ltd. | DZB Orthodontic Extraoral Headgear |
| 22 Dec 2005 | K052553 | NITOM LOCKING FACEBOW | Russell Samuels Orthodontic Design | DZB Orthodontic Extraoral Headgear |
| 22 Jul 2005 | K051751 | EQUA-PULL SAFETY RELEASE MODULE | Ortho Technology, Inc. | DZB Orthodontic Extraoral Headgear |
| 15 Oct 2004 | K041718 | KELES FACEMASK | Great Lakes Orthodontics, Ltd. | DZB Orthodontic Extraoral Headgear |
| 22 Oct 2003 | K032392 | MORALES PROTRACTION FACEMASK | Fernando Morales Garfias | DZB Orthodontic Extraoral Headgear |
| 9 Jun 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology, Inc. | DZB Orthodontic Extraoral Headgear |
| 11 Feb 2000 | K993224 | T-GEAR, MODEL TG/400-700 | Dontech Products B.V. | DZB Orthodontic Extraoral Headgear |
| 4 Sep 1998 | K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 27 Apr 1998 | K980436 | CLASS III REVERSE PULL FACEMASK | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 21 Apr 1998 | K980245 | NITOM LOCKING FACEBOW | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 6 Apr 1998 | K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 11 Mar 1998 | K980195 | FACEBOW | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 23 Apr 1997 | K970930 | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | Cleft Palate Appliances, Inc. | DYJ Orthodontic Screw Expansion Retainer |
| 10 Jul 1996 | K961754 | SAFETY RELEASE MODULE | G&H Wire Company | DZB Orthodontic Extraoral Headgear |
| 14 Feb 1996 | K955528 | CLP BONNET | Clp Products | DZB Orthodontic Extraoral Headgear |
| 14 Apr 1995 | K931615 | NITE-GUIDE | ORTHO-TAIN, Inc. | KMY Preformed Tooth Positioner |
| 8 Mar 1995 | K950121 | FRANCE ORTHODONTIE | France Orthodontie | DZB Orthodontic Extraoral Headgear |
| 13 Feb 1995 | K942667 | DENT-O-CRYL ORTHODONTIC ACRYLIC | Dentauraum, Inc. | KMY Preformed Tooth Positioner |
| 1 Aug 1994 | K936151 | EXTRAORAL HEADGEAR | Dentauraum, Inc. | DZB Orthodontic Extraoral Headgear |
| 28 Apr 1994 | K935856 | DENTAURUM SPACE MAINTAINER | Dentauraum, Inc. | DYT Orthodontic Space Preformed Maintainer |
| 10 Mar 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 3 Feb 1994 | K935154 | DENTAURUM EXPANSION SCREWS | Dentauraum, Inc. | DYJ Orthodontic Screw Expansion Retainer |
| 6 Jan 1994 | K924351 | GLENROE ELASTIBITE STIMULATOR | Glenroe Technologies | KMY Preformed Tooth Positioner |
| 7 Oct 1993 | K932761 | SOFT-WEAR HEADGEAR AND SAFETY MODULES | Professional Positioners, Inc. | DZB Orthodontic Extraoral Headgear |
| 13 Sep 1993 | K925064 | RELAX-O-GUARD | Aquatemp Service Co., Inc. | KMY Preformed Tooth Positioner |
| 8 Jul 1993 | K924975 | THE ORTHOTRAINER | Myofunctional Research Co. Usa Inc. | KMY Preformed Tooth Positioner |
| 23 Jun 1993 | K924974 | THE TMJ APPLIANCE | Myofunctional Research Co. Usa Inc. | KMY Preformed Tooth Positioner |
| 18 Jun 1993 | K925240 | FACEBOW | Forestadent Bernhard Forster GmbH | DZB Orthodontic Extraoral Headgear |
| 22 May 1993 | K925088 | EXPANSION SCREWS | Forestadent | DYJ Orthodontic Screw Expansion Retainer |
| 4 Dec 1992 | K923556 | ADP FACEMASK | Sybron Dental Specialties | DZB Orthodontic Extraoral Headgear |
| 20 Mar 1992 | K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | Gac Intl., Inc. | DZB Orthodontic Extraoral Headgear |
| 20 Dec 1991 | K912417 | MOLAR DISTALIZING ASSEMBLY | American Orthodontics | DYJ Orthodontic Screw Expansion Retainer |
| 9 Dec 1991 | K912682 | ORTHODONTIC HEADGEAR | K-Tek Orthodontic Products | DZB Orthodontic Extraoral Headgear |
| 9 Nov 1990 | K904128 | PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER | American Orthodontics | KMY Preformed Tooth Positioner |
| 6 Sep 1990 | K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | Sybron Dental Specialties | DZB Orthodontic Extraoral Headgear |
| 6 Sep 1990 | K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL | Sybron Dental Specialties | DZB Orthodontic Extraoral Headgear |
| 30 Jul 1990 | K901958 | GUARDIAN SAFE BOW | Lancer Orthodontics, Inc. | DZB Orthodontic Extraoral Headgear |