Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Elastic Band
FDA device type “Band, Elastic, Orthodontic”.
- Companies listing it
- 11574 makers
- Brands and models
- 350
- 510(k) clearances
- 250 in five years
- FDA name
- Band, Elastic, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list ECI
115 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 | Arch Wire Sleeve · Clear Rotation Wedges · Colored Chain · E-Z Tie Tubing · +9 | 44 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | BRACE COVER · Bulk Elastics · BULK LIGATURE TIES · Bumper Sleeve · +60 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Bump-R-Sleeve tubing · E-Chain · E-Links · Elastics · +11 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | Elastics and ligatures | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics | 1 | 2025 |
| Ortho Kinetics Corp. | United States | Maker | Power Coins Glow in the Dark Ligatures | 7 | 1998 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Mediloy RPD | 4 | 2013 |
| GNI Co., LTD | South Korea | Maker | BAND, ELASTIC | 3 | 2021 |
| Dentos, Inc. | South Korea | Maker | M4-C · M4-G · M5-C · M5-G · +10 | 2 | 2019 |
| G&H Wire Company | United States | Maker | BAMBINO-TIES · DESIGNERTIES® · DYNA-LINK · ENCHANTED SERIES · +10 | 2 | 2008 |
| GC Orthodontics | United States | Maker | — | 2 | 2015 |
| World Bio Tech Co Ltd | South Korea | Maker | Elastomerics ; Intraoral Elastics, Power Chain, Ligature Ties, Separators, Thread, Tubing, Rotation Wedge | 2 | 2016 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| World Class Technology Corporation | United States | Maker | orthodontic elastic band- multiple | 1 | 2019 |
| Bioseal | United States | Maker | sterile bands | 1 | 1988 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Dentalastics · Dentalastics plastic ligature · Dentalastics separator · Elasto-Force plastic chain · +3 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Arch Wire · bandage · Elastane Chain · elastic material · +6 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Ligature Tie/Separator Elastormeric/Elastane Chain/Orthodontic Elastics, Elastane chain | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ORTHOFLEXY ELASTOMERIC · ORTHOMETRIC ELASTOMERICS - BLACK LATEX · ORTHOMETRIC ELASTOMERICS - CHAIN · ORTHOMETRIC ELASTOMERICS - ELASTIC POSITIONER · +9 | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Elastic Placers | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Band, Elastic, Orthodontic · Band, Elastic, Orthodontic (All types of orthodontic Elastic Bands, Power Chain, Sleeve, Thread, Seperator) · Orthodontic Elastics | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | BAND, ELASTIC, ORTHODONTIC | — | — |
| Aditek do Brasil SA | Brazil | Maker | Elastomerics · Intraoral elastics · Stick Tie | — | — |
| Solventum US LLC | United States | Maker | Action Line Thread and Tubing · AlastiK Ligatures, Chain, Separators, Modules · Lingual Rotation Wedge · Orthodontic Elastics | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | SIA ORTHODONTIC MANUFACTURER | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Orthodontic Rubber Chain and Ligature Tie | — | — |
| Innovative Material And Devices, Inc. | China | Maker | Hestia Intraoral Elastics (variety of shape, color, size and length), Hestia Separators · Hestia Ligature Ties (variety of shape, color, size and length), Hestia Power Chain (variety shape, color, size and leng · (variety of shape, color, size and length), Q-Peak Separators (variety of shape, color, size and length) | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Orthodontic arch wire,Orthodontic band,Orthodontic buccal tube · Polishing brush,Elastance chain,Ligature tie,Orthodontic Bracket,tooth model,Orthodontic kit · Separator elastormeric,probe (forceps),Orthodontic elastic | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Astar Orthodontics Inc | China | Maker | ligature elastic, cat shape · ligature elastic, flower shape · ligature elastic, mouse shape | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Brace elastics | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | BAND, ELASTIC, ORTHODONTIC | — | — |
| Ortho Solutions LC | United States | Maker | — | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Band, Elastic, Orthodontic | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Band, elastic, orthodontic | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic bands | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Elastic Band | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental, Orthodontic ligature ties | — | — |
| Sino Ortho Limited | China | Maker | orthodontic elastic, tie | — | — |
| Zhejiang Headway Medical Equipment Co., Ltd. | China | Maker | Orthodontic Bands | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Angsheng, Orthodontics World | — | — |
| O&S Dental Inc | United States | Maker | Top Elastics, Top Chain, Top Sticks, Separators | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Elastic Orthodontic Band | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Elastics | — | — |
| American Angle Ortho, LLC | United States | Maker | Donuts Elastic, Donuts Elastomeric Ligature Ties, Donuts Power Chains, · Donuts Rotaition Wedges, Donuts Bumper Tubing, Donuts Separators | — | — |
| Funing Meitedental Factory | China | Maker | Orthodontic bands, Latex Elastics, Orthodontic elastomeric, Orthodontics Elastics, Ligate Ties, Power Chain | — | — |
| Libral Traders Pvt Ltd | India | Maker | Elastomeric Archwire Tubing, Intraoral Extraoral Elastics, Ligature Ties, Separators | — | — |
| Modern Orthodontics | India | Maker | ElastoSure | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | ligature tie orthodontics/orthodontic elastic rubber bands/power chain/Orthodontic Elastic Band/ · Orthodontic Appliance and Accessories | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | Band, elastic, orthodontic | — | — |
| Tangent Technologies LLC | United States | Maker | Elastic Separators; Elastic Thread; Elastics; Energy Chain; Elastomeric Ligatures; Rotation Wedge | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Orthodontic elastic | — | — |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd | China | Maker | Ortho Elastics | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Orthodontic Elastic Band | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Creative Dental | China | Maker | Band Elastic | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Orthodontic Elastics | — | — |
| JINHUA GLAMB MEDICAL EQUIPMENT Co., Ltd. | China | Maker | Orthodontic Elastomerics | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Yancheng Denrum Medical Apparatus Co Ltd | China | Maker | Orthodontic Elastomer | — | — |
| Auradonics Inc | United States | Maker | BAND · , elastic, orthodontic | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | Orthodontic Elastics including separator, power chain, O-ring, Elastic etc | — | — |
| proNet, A Desco Industries Inc. Brand | United States | Maker | — | — | — |
| Snapz Innovations Inc | United States | Maker | Snapz Tasty Bands | — | — |
| Taurus Engineering and Manufacturing, Inc. | United States | Maker | — | — | — |
| Eagle Mold Technologies, Inc. | United States | Maker | — | — | — |
| Icp, Inc. | United States | Maker | — | — | — |
| Polymer Engineering Laboratories Ltd. | Japan | Maker | — | — | — |
| Yuwa Seisakusho KK | Japan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | Relastics | 32 | 2021 |
| Biomet Microfixation | United States | Manufacturer | Orthodontic Band · Rubber Band | 8 | 2021 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | Colour Boutique Chain · Colour Boutique Elastomeric Ligatures | 2 | 2010 |
| Rmo, Inc. | United States | Manufacturer | ELASTIC SEPARATORS; Elastic Thread; Elastics; Energy Chain; RMO ELASTOMERIC LIGATURES; Rotation Wedge | 1 | 1990 |
| Sawbros Industries Pvt., Ltd. | India | Manufacturer | SEPARATOR, ORTHODONTIC | 1 | 2017 |
| Sotera Health LLC | United States | Contract manufacturer | Band, Elastic, Orthodontic · 14002/100 · 14004/100 · 14005/100 · +64 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental elastic. · dental Speparator · ligature tie · Natural Elastic · +1 | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Intra Oral Latex Elastics · JMU Intra Oral Latex Free Elastics · JMU JMU Intra Oral Elastics Neon · JMU Ligature O-Ties · +5 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Plastic Ligature | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Ligature chain; Ligature ties; lip bumer tubing; Orthodontic elastomeric; rotation wedges; separators; thread · Orthodontic appliance and accessories ,elastomeric modules; Extraoral; Intraoral | — | — |
| Practicon, Inc. | United States | Manufacturer | PRACTICON LIGATURE TIES | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | IOS Ligature Ties · Mini Ligature O - Ties 15-112-100 to 134 · Ultimate Power Chain | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Amber Interoral Elastics, Rainbow Interoral Elastics, Non-Latex Clear Interoral Elastics · Elastomeric Tissue Guard, Elastomeric Thread & Tubing, Rotation Wedges · Glide-Ties, Elastic Chains, Elastomeric Separators | — | — |
| Csy International LLC | United States | Repacker / relabeler | Caber · J&J Ortho · J&J Orthodontics | — | — |
| Forestadent Usa | United States | Repacker / relabeler | BAND | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Band, Elastic, Orthodontic | — | — |
| battech | United States | Repacker / relabeler | orthodontics elastic band | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Orthodontic Arch Wire,Orthodontic Band,Orthodontic Buccal Tube · Polishing Brush,Elastance Chain,Ligature Tie,Orthodontic Bracket,Tooth Model,Orthodontic Kit · Separator Elastormeric,Probe (Forceps),Orthodontic Elastic | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Integrity | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | — | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Elastic Band | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | ELASTICS · ELASTOMERIC TIES · ELASTOTIES | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Elastic Chain, 15ft · Advance Elastic Chain, 5ft · Advance Elastic Separators | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Endura High Performance Chain · Spectrum Elastomerics | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Saga Dental Supply A | Norway | Contract manufacturer | band | — | — |
| Mirabay Orthodontics Corporation | United States | Repacker / relabeler | Mirabay Elastomeric | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| JM Ortho Corporation | Japan | Foreign exporter | Energy Chain · Energy Thread · K-2 O-Ring · Tough-O | — | — |
| Cx Orthodontic Supply | United States | Repacker / relabeler | CX Ortho Supply | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| SDP Inc. | Canada | Repacker / relabeler | SDP ELASTIC BAND | — | — |
| Cardinal Health 200, LLC | United States | Manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Toyo Polymack Co., Ltd. | Japan | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Apr 1998 | K980864 | POWER COINS GLOW IN THE DARK LIGATURES | Ortho Kinetics Corp. |
| 24 Feb 1998 | K980053 | GLENROE CHAIN | Glenroe Technologies |
| 1 Dec 1997 | K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | Glenroe, LLC |
| 24 May 1995 | K943419 | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | Jon-Ko Products, Inc. |
| 23 May 1995 | K943420 | ORTHODONTIC ELASTOMERIC CHAIN | Jon-Ko Products, Inc. |
| 23 May 1995 | K943418 | ORTHODONTIC ELASTOMERIC SEPARATOR MODULE | Jon-Ko Products, Inc. |
| 23 May 1995 | K943417 | ORTHODONTIC ELASTOMERIC TUBE/THREAD | Jon-Ko Products, Inc. |
| 7 Mar 1994 | K940165 | ALASTIK | Unitek Corp. |
| 14 Feb 1994 | K932298 | PRO'S NEO-LASTICS | Professional Positioners, Inc. |
| 4 Feb 1994 | K935144 | DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS | Dentauraum, Inc. |
| 20 Sep 1993 | K932319 | ORTHODONTIC ELASTOMER | Gac Intl., Inc. |
| 22 Jul 1993 | K931462 | GLENROE CHAIN | Glenroe Technologies |
| 24 Jun 1993 | K923999 | ALASTIK NS | Unitek Corp. |
| 27 May 1993 | K930453 | SINGLES | Nexadental |
| 27 Apr 1993 | K924140 | TUFF TIES | Glenroe Technologies |
| 8 Apr 1993 | K924139 | GLENROE ORTHO SEPS | Glenroe Technologies |
| 31 Mar 1993 | K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | American Orthodontics |
| 13 Oct 1988 | K882695 | RUBBER BAND, STERILE | Bioseal |
| 31 Jul 1985 | K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | A Company, Inc. |
| 31 Jul 1985 | K852599 | A-COMPANY ELASTOMERIC TUBING | A Company, Inc. |
| 31 Jul 1985 | K852598 | A-COMPANY SEPARATING ELASTICS | A Company, Inc. |
| 31 Jul 1985 | K852597 | A-COMPANY ELASTIC ROTATION WEDGES | A Company, Inc. |
| 31 Jul 1985 | K852596 | A-COMPANY ELASTIC LIGATURE RINGS | A Company, Inc. |
| 28 Jan 1981 | K810010 | ORTHODONTIC ELASTICS | Orec Corp. |
| 14 Jun 1978 | K780804 | HYGIENIC ANCHORINGS | Hygienic Dental Mfg., Co., The |
Official records: FDA product classification for ECI · 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