Surgical devices · 21 CFR 872 Subpart E
Orthodontic Bracket Aligner
FDA device type “Aligner, Bracket, Orthodontic”.
- Companies listing it
- 7855 makers
- Brands and models
- 139
- 510(k) clearances
- 20 in five years
- FDA name
- Aligner, Bracket, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list ECQ
78 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 |
| Ortho Organizers, Inc. | United States | Maker | BOONE GAUGE · Bracket Placing Tweezer · BRACKET POSITIONER/PLACER · Bracketizer (multiple) · +6 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | EDGEWISE BRACKETS · 256 BRACKETS | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | Bracket positioning gauges | 4 | 2025 |
| uLab Systems, Inc. | United States | Maker | — | 4 | 2022 |
| Kline Europe GmbH | Germany | Maker | CLEAR X · K Clear | 1 | 2022 |
| Progressive Aligners Inc | United States | Maker | — | 1 | 2024 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho | 3 | 2021 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Biotech Dental Smilers, SAS | France | Maker | SMILERS | 1 | 2021 |
| Zain's Medical Image | Pakistan | Maker | Anterior Bonding Tweezers, Non-Reverse Action · Anterior Bracket Holder Tweezers · Anterior Bracket Holder Tweezers with Aligner · Anterior Bracket Holder Tweezers, Non-Reverse · +32 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Aligner · Bracket · Plastic jig aligner | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | aligner removal | — | — |
| Medcave Private Limited | Pakistan | Maker | Aligner Bracket | — | — |
| Panorama International | Pakistan | Maker | ALIGNER, BRACKET, ORTHODONTIC | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Orthodontic Brackets | — | — |
| Accompany Surgical | Pakistan | Maker | Bracket Holder · Bracket Placer | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Aligner, bracket, orthodontic | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | aligner, bracket, orthodontic | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | — | — | — |
| Denta Craft Instruments | Pakistan | Maker | Bracket Holder; Bracket Placer | — | — |
| Solventum US LLC | United States | Maker | Boone Bracket Positioning Gauge | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Huizhou Videya Technology Co., Ltd. | China | Maker | Aligner Chewies | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Chewies | — | — |
| Maryam Trading | Pakistan | Maker | ALIGNER, BRACKET, ORTHODONTIC · MARYAM TRADING · Multi | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | Eurodonto · Protect | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Aligner removal tool | — | — |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | China | Maker | Dental Aligner, Aligner Remover, Dental Elastic Director | — | — |
| Ekong Technology Co., Limited. | China | Maker | Aligner removal tool, Aligner removal, Retainer removal | — | — |
| SGS Export Intl. | Pakistan | Maker | Aligner, Bracket, Orthodontic | — | — |
| Shenzhen Golden Wish Personal Care Co.,Ltd | China | Maker | Aligner Chewies, Orthodontic Dental aligner, OT-02, OT-03, OT-04, OT-05, OT-06, OT-07, OT-08, OT-09, OT-10 | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | ALIGNER, BRACKET, ORTHODONTIC | — | — |
| Huizhou Gold Rose Technology Co.,Ltd | China | Maker | Brace | — | — |
| Richbolt Enterprises | Pakistan | Maker | RICHBLOT ENTERPRISES | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | ALIGNER, BRACKET, ORTHODONTIC | — | — |
| Coral Healthcare Products Manufacturer Co., Ltd. | China | Maker | ALIGNER CHEWIES, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D603, D653, S451, S452, · ALIGNER CHEWIES, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S453, DM01, AC01 · ALIGNER CHEWIES, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600 | — | — |
| Ghousia Amanat Surgical | Pakistan | Maker | Bracket Tweezer | — | — |
| Saga Dental Supply A | Norway | Maker | Aligner · Herbst · Herbst or MALU · MALU | — | — |
| Ameda Instruments Company | Pakistan | Maker | Bracket Gauge · Mirror Handles | — | — |
| Dxin Trading HK Co., Limited | China | Maker | Clear aligner | — | — |
| Hefei Jingcheng Plastic Products Co. Ltd | China | Maker | HP MIXING TIPS | — | — |
| Huile Denture Technology (Hong Kong) Co Limited | China | Maker | Clear aligner | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Dental Brackets;DTC;Orthodontics | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| IDM Tooling LLC | United States | Maker | Clenchy · Clenchy 2 · Clenchy Tongue Cleaner · Clenchy U | — | — |
| Creative Dental | China | Maker | Bracket | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Istar dental lab | China | Maker | Clear Aligner: Essix and TPU | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Innovation MediTech GmbH | Germany | Maker | Indirect Bonding Tray | — | — |
| MYT USA Corp | United States | Maker | ALIGNER, BRACKET, ORTHODONTIC · TUBE, ORTHODONTIC · WIRE, ORTHODONTIC | — | — |
| Shenzhen Robust Dental Laboratory Co., Limited | China | Maker | Aligner, Bracket, Orthodontic · Screw Appliance, mouth guards, screw expanders | — | — |
| Dongguan Hengrui Silicone Products Co., Ltd. | China | Maker | Aligner Chewies | — | — |
| Hype Align Clear Orthodontics, Limitada | Costa Rica | Maker | Hype Align | — | — |
| Wuxi EA Medical Instruments Technologies Limited | China | Foreign exporter | Aligner Chewies | 2 | 2023 |
| G&H Wire Company | United States | Contract manufacturer | n/a | 2 | 2008 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL ALIGNER · invisable bracket · orthodontic bracket | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Mixing Tips | — | — |
| Practicon, Inc. | United States | Manufacturer | SmileGoods Aligner Chewies · Smilegoods Aligner Remover · Smilegoods Right-Bite Aligner Seaters | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Reverse Action Keat Molar Tube Placer · Vanish Twin, Vanish SLB | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Tips | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Aligner Chewies · Aligner Hook / Remover | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Aligner, Bracket, Orthodontic | — | — |
| battech | United States | Repacker / relabeler | Aligner removal tool/ Aligner removal tool/Aligner removal tool/ Aligner removal tool | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Integrity | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | BRACKET, AESTHETIC, ORTHODONTICS | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | Aligner Removal Tool | — | — |
| Hangzhou HaiZhu MIM products Co., Ltd | China | Foreign exporter | Bracket | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Ezcad Dental Lab | United States | Repacker / relabeler | Clear Aligner, Ezclear Aligner | — | — |
| Pg Supply, Inc. | United States | Repacker / relabeler | Premium Line Dental Brackets | — | — |
| Allure Ortho | United States | Repacker / relabeler | EC CERTIFICATION | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 31 Jan 1994 | K935153 | DENTAURUM BRACKET POSITIONING GAUGE | Dentauraum, Inc. |
| 29 Apr 1985 | K851454 | A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS | A Company, Inc. |
Official records: FDA product classification for ECQ · 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