Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Screw Expansion Retainer
FDA device type “Retainer, Screw Expansion, Orthodontic”.
- Companies listing it
- 11794 makers
- Brands and models
- 515
- 510(k) clearances
- 50 in five years
- FDA name
- Retainer, Screw Expansion, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list DYJ
117 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| SprintRay Inc. | United States | Maker | Retainer (Clear, Natural, Black, Pink, Neon Green) | 8 | 2026 |
| Sybron Dental Specialties | United States | Maker | ACCO Expander · Acrylic Bonded RPE · Activators · Adaptor · +50 | 203 | 2026 |
| American Orthodontics | United States | Maker | Alexander Lip Bumper · Cantilever Bar Offset · Distal Jet · Gentle Jumper · +24 | 44 | 2026 |
| Vivos Therapeutics, Inc. | United States | Maker | Facialblocks · V-Starter Kids; V-Starter PreTeen; Vivos Grow (VG); Vivos Guide System; Vivos Way (VW) | 3 | 2024 |
| Detax GmbH | Germany | Maker | dx retainer 1000g · dx retainer 5kg · FREEPRINT splintmaster flex 1000g · FREEPRINT splintmaster taff 1000g · +5 | 2 | 2025 |
| Ortho Organizers, Inc. | United States | Maker | Expabent Expansion Screw · Expansion Screws · Intraoral Appliances- Multiple · Lombardi Bionator Bite Appliance · +7 | 8 | 2025 |
| Biomaterials Korea, Inc. | South Korea | Maker | KBE II-10 · KBE II-12 · KBE II-6 · KBE II-8 · +57 | 5 | 2023 |
| Tp Orthodontics, Inc. | United States | Maker | Accufit retainer · Baurmash bondable Arch Bar · Bondable Lingual Retainer · Flip-Lock Herbst Appliance · +4 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | LEONE EXPANDERS · Mandibular advancers · Thermoplastic material | 4 | 2025 |
| Microware Precision Co., Ltd. | Taiwan | Maker | QS Screw | 2 | 2022 |
| MK Meditech | South Korea | Maker | ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ | 1 | 2021 |
| Beame Medical Technology (Shenzhen) Limited | China | Maker | Retainer | 1 | 2026 |
| 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 | 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 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Rmo, Inc. | United States | Maker | Quad Helix, Multi-Action Appliance, Palatal Appliance, Adapter · Rapid palatal expander · Zero Corrector | 1 | 1990 |
| Apnomed, Inc. | United States | Maker | ApnoMed TEEN · ApnoTx Orthodontic Appliance · DAMES Distraction Assisted Mandibular Expander · MAPE Micro-Implant Assisted Protractor Expander | 1 | 2018 |
| ASO International Manila, Inc. | Philippines | Maker | — | 1 | 2021 |
| 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 · +28 | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Activator · Adult Split Bionator · Anterior Sagittal w/ S Bow · Aussie Wire 3X3 · +103 | — | — |
| 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 · +16 | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ICERAM CLEAR DISTALIZER | — | — |
| 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 | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Biocryl Form-X · Endure · GREAT LAKES BIOCRYL · Invisacryl · +5 | — | — |
| Aditek do Brasil SA | Brazil | Maker | Memoflex Copolyester; Memoflex PETG; Memoflex TPU | — | — |
| 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 | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Mount Blonck Trading | Pakistan | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| one day dental partner | South Korea | Maker | kage RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Retainer, Screw Expansion Orthodontic | — | — |
| Xplora USA LLC | United States | Maker | Six Month Smiles | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Retainer, Screw Expansion, Orthodontic | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | BONE TAC · ORTHODONTIC SCREW | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Hawley Retainer · Retainer | — | — |
| Scheu-Dental GmbH | Germany | Maker | Herbst · IST Appliance · Orthodontic Retainer · Telescopes · +1 | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic retainer screw expansion · Orthodontic universal lingual retainers | — | — |
| 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 | — | — |
| Sino Ortho Limited | China | Maker | lingual retainer, dental screw | — | — |
| Beijing Smart Technology Co., Ltd | China | Maker | Preformed NiTi Retainer | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Retainer, Screw Expansion, Orthodontic | — | — |
| 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 | — | — |
| 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 | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Shenzhen Baotonghui Industrial Co.,Ltd | China | Maker | Orthodontic accessories | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| 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 | — | — |
| 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 | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Alta Smiles, Inc | United States | Maker | Retain | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Orthodontic Expansion Screw | — | — |
| 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 | — | — |
| 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, | — | — |
| KTJ Dental Lab Inc. | United States | Maker | RETAINER,SCREW EXPANSION, ORTHODONTIC | — | — |
| Thanh Dental Laboratory | Vietnam | Maker | Thanh Dental Lab Dental Restorations | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | 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 | — | — | — |
| LEWA-DENTAL Feinmechanik GMBH & CO. KG | Germany | Maker | Lewa-Dental Expansion Screws | — | — |
| 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 | — | — |
| Tiger Dental GmbH | Austria | Maker | PowerScrew | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| Edental Lab Co., Ltd | China | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Palaxa Precision LLC | United States | Maker | — | — | — |
| Uniontech, SRL | Italy | Maker | — | — | — |
| Dentsply Sirona, Inc. | United States | Contract manufacturer | — | 148 | 2026 |
| Voco GmbH | Germany | Foreign exporter | V-Print ortho | 117 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Leone Series | 23 | 2025 |
| Sawbros Industries Pvt., Ltd. | India | Manufacturer | Retainer Wire | 1 | 2017 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Forward Pull Headgear | — | — |
| 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 · +1 | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| Forestadent Usa | United States | Repacker / relabeler | RETAINER · SCREW EXPANSION | — | — |
| Solventum US LLC | United States | Contract manufacturer | Orthodontic Expansion Screws · 3M Unitek | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Retainer, Screw Expansion, Orthodontic | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Retainer, Mouthguard, Bite Guard | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Screws | — | — |
| Guangzhou OO Medical Scientific Limited | China | Foreign exporter | OO Dental, Retainer, Screw Expansion | — | — |
| DigiSmiles Lab | United States | Repacker / relabeler | Retainer Screw Expansion Orthodontic | — | — |
| GLO Science, Inc. | United States | Contract manufacturer | Six Month Smiles Retainer | — | — |
| KTJ Dental Lab Company Limited | Hong Kong SAR China | Private-label distributor | RETAINER, SCREW EXPANSION, ORTHODONTIC | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | ORTHODENTALUSA CORP | — | — |
| Orthodontic Supply & Equipment Co., Inc. | United States | Repacker / relabeler | Scandee Dental Retractors · Ultimate Ball Retainer Clasps | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Apr 1997 | K970930 | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | Cleft Palate Appliances, Inc. |
| 3 Feb 1994 | K935154 | DENTAURUM EXPANSION SCREWS | Dentauraum, Inc. |
| 22 May 1993 | K925088 | EXPANSION SCREWS | Forestadent |
| 20 Dec 1991 | K912417 | MOLAR DISTALIZING ASSEMBLY | American Orthodontics |
| 14 Nov 1984 | K843705 | MANDIBULATOR JAW POSITIONER | A Company, Inc. |
Official records: FDA product classification for DYJ · 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