Surgical devices · 21 CFR 872 Subpart E
Orthodontic Band Setter
FDA device type “Setter, Band, Orthodontic”.
- Companies listing it
- 6042 makers
- Brands and models
- 66
- 510(k) clearances
- 30 in five years
- FDA name
- Setter, Band, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list ECR
60 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | Retainer Retriever | 8 | 2025 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho | 3 | 2021 |
| Storz AM Mark GmbH | Germany | Maker | Band setter, Ligature Applicator | 2 | 2008 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Band seater · Band setter · Molar band seater | — | — |
| 株式会社ＹＤＭ | Japan | Maker | Arch Wire Director · Band Seater YS-703 · Ligature Director YS-704A Twister · Ligature Director YS-704B Double End | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Aligner Chewies, Retainer Retrievers, Invisible Braces Box | — | — |
| Technimen Skillers | Pakistan | Maker | BAND SEATER · BAND SETTER · BITE STICK · ENTAL · +3 | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Setter, Band, Orthodontic | — | — |
| Nordent MFG., Inc. | United States | Maker | Nordent Band Seater | — | — |
| Panorama International | Pakistan | Maker | SETTER, BAND, ORTHODONTIC, Band Setters | — | — |
| Accompany Surgical | Pakistan | Maker | Band Seater | — | — |
| Lacigrus International | Pakistan | Maker | SETTER, BAND, ORTHODONTIC | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | SETTER, BAND, ORTHODONTIC | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | Band Seater | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | G140-00 Power Chain Closed, G200-00 Rotation Wedges, G150-00 Intraoral Elastic 2.5oz; G160-00 Intraoral Elastic 3.5oz, · G170-00 Intraoral Elastic 4.5oz, G180-00 Intraoral Elastic 6.5oz, G190-00 Separator. · Orthodotnic Elastics, Orthodontic Hooks; G110-00 Ligature Tie, G120-00 Power Chain Long, G130-00 Power Chain Short, | — | — |
| Otto Leibinger GmbH | Germany | Maker | DOUBLE SIDED BAND SETTE | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | Forced Positioner L · Forced Positioner R | — | — |
| Solventum US LLC | United States | Maker | Molar Band Seater | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Mident Ltd | United Kingdom | Maker | Band Setter | — | — |
| Produits Dentaires SA | Switzerland | Maker | Universal Solder | — | — |
| Qibei Technology Co., Limited | China | Maker | Orthodontic appliances and accessories · OT100,OT101,OT102,OT103,OT105,OT106 | — | — |
| Daddy D Pro | Pakistan | Maker | SETTER, BAND, ORTHODONTIC | — | — |
| Everbrands, Inc. | United States | Maker | EverSmile OrthoChews · FastTrack Aligner Seater · Invisalign Aligner Seaters | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodotnic Elastics, Orthodontic Hooks, Aligner Chewies, Retainer Retrievers, Invisible Braces Box (ALIGNER BOX) | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Denture Case; Retainer Case; Retainer Box;Denture Box,Invisible Braces Box,Mouth Guard Case | — | — |
| Karl Hammacher GmbH | Germany | Maker | Karl Hammacher GmbH | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Hooks | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| EOCA MD Pty Limited | Australia | Maker | Munchies® VIBE | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Movemints, LLC | United States | Maker | Movemints | — | — |
| Ortho Attachyhook Supply LTD. | Canada | Maker | Attachyhook button | — | — |
| Chewly Pty. Ltd. | Australia | Maker | iChew Aligner Seater | — | — |
| Filip Albert Amram Jaws Gida Sanayi Ve Ticaret Sirketi | Türkiye | Maker | Movemints Confidential: no | — | — |
| A. Handte Medizintechnik GmbH & Co. KG | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Park Dental Research Corp | United States | Contract manufacturer | Orthodontic Accelerator | 8 | 2026 |
| Biomet Microfixation | United States | Manufacturer | Band Pusher | 8 | 2021 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | cheek retractor | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Band Setter | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | SETTER, BAND, ORTHODONTIC | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | SmileSet Aligner/Retainer Seater/Removal Tool | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Infinity | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | Munchies® VIBE | — | — |
| Axiom Marketing, Inc. | United States | Repacker / relabeler | Aligner Chewies, Retainer Retrievers, Invisible Braces Box | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Vehu Medical Instrumente GmbH | Germany | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 May 1995 | K951776 | BAND SEATER | Sybron Dental Specialties |
| 3 Feb 1994 | K935156 | DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS | Dentauraum, Inc. |
| 27 Sep 1984 | K843018 | FLEXI-POST | Essential Dental Systems, Inc. |
Official records: FDA product classification for ECR · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026