Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Tube
FDA device type “Tube, Orthodontic”.
- Companies listing it
- 10879 makers
- Brands and models
- 662
- 510(k) clearances
- 80 in five years
- FDA name
- Tube, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list DZD
108 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 | Convertible Double · Convertible Singel · Convertible Triple · Cross Tubes · +19 | 44 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | BUCCAL TUBE · BUCCAL TUBES AND ATTACHMENTS · Crimpable Cross Tubes · Crimpable Double Tubes · +7 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Bondable Molar tubes · BUCCAL TUBES · Cast Begg Molar Tubes · Cast Tip-Edge Molar Tubes · +6 | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | METAL TUBES · MIM | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Ze Fang Technology Co., Ltd. | Taiwan | Maker | SD Mini Tube LL7-DQ18 · SD Mini Tube LL7-DQ22 · SD Mini Tube LL7-EDGEWISE18 · SD Mini Tube LL7-EDGEWISE22 · +84 | 1 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Buccal Tubes/ | 1 | 2025 |
| Ultimate Wireforms, Inc. | United States | Maker | BUCCAL TUBE · BUCCAL TUBES · TUBE STOPS | 6 | 1996 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Flat- Line Buccal Tubes | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | TUBE | 3 | 2021 |
| G&H Wire Company | United States | Maker | AGILITY · CANNON ULTRA · KLO · MAGNUM · +5 | 2 | 2008 |
| GC Orthodontics | United States | Maker | GC Orthodontics | 2 | 2015 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Rmo, Inc. | United States | Maker | Orthodontic Tubes | 1 | 1990 |
| World Class Technology Corporation | United States | Maker | BioMini · H4/Pitts21 | 1 | 2019 |
| ASO International Manila, Inc. | Philippines | Maker | Double Tube (DT) · Tube for Forsus | 1 | 2021 |
| Hespeler Orthodontics Ltd | Canada | Maker | BUCCAL TUBE KIT 18 · BUCCAL TUBE KIT 22 · CSTKIT18L6-10 · CSTKIT18L6-24 · +334 | — | — |
| Zain's Medical Image | Pakistan | Maker | Aspirator Tip · Surgical Aspirator Tips | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Buccal · Buccal tube · Ortho · Ortho buccal tube · +7 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Buccal Tubes | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ADVANCED SERIES TUBES · BIOVERSATIL TUBES · CAPELOZZA TUBES · ICERAM MINI TUBES · +4 | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Tube, Orthodontic · Tube, Orthodontic (All type of Buccal Tube) · Westlake | — | — |
| Aditek do Brasil SA | Brazil | Maker | TruSinter | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | B103-21 Bondable 1st Convertible Slot 022 Edgewise Buccal Tube; · B104-11 Bondable 1st Non-Convertible Slot 018 Edgewise Buccal Tube; · B104-21 Bondable 1st Non-Convertible Slot 022 Edgewise Buccal Tube; · B106-21 Weldable 1st Non-Convertible Slot 022 Roth Buccal Tube; · +14 | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | L-Tube 2mm · L-Tube 3mm · LPA 022 tube 1mm · LPA 022 tube 2mm · +9 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | JET · JET LP · SIA ORTHODONTIC MANUFACTURER · ZIP T6 · +1 | — | — |
| Innovative Material And Devices, Inc. | China | Maker | ActMIM Roth+ Buccal Tubes, Pluto Plus Buccal Tubes, ProMIM X Buccal Tubes, FOMIC Buccal Tubes | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | Eurodonto · Protect | — | — |
| Nadir & Co. | Pakistan | Maker | Tube Holding Forceps | — | — |
| Astar Orthodontics Inc | China | Maker | Mico¿ tubes | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | TUBE, ORTHODONTIC | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodontic Tube | — | — |
| Specialty Appliances, LLC | United States | Maker | Archwire Tubes | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Tube, Orthodontic | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho TUBE, ORTHODONTIC | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic buccal tube | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Orthodontic Tube | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Tube | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental, O-Tube | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT ORTHODONTIC TUBE - 1DERFUL ORTHODONTIC TUBE | — | — |
| Win Wings Corp. | Pakistan | Maker | TUBE, ORTHODONTIC | — | — |
| Sino Ortho Limited | China | Maker | buccal tube, molar tube | — | — |
| Alframed | Pakistan | Maker | surgical aspirator, 2.5mm tip | — | — |
| Waqas Surgical Instruments | Pakistan | Maker | fraizeir tube · fraizeir tube/needle · Pool section tube · younker tube, | — | — |
| Zhejiang Headway Medical Equipment Co., Ltd. | China | Maker | Orthodontic Buccal Tubes | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Tube Orthodontic | — | — |
| O&S Dental Inc | United States | Maker | Orthodontic Tubules | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Orthodontic Tube | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Tube | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | TUBE | — | — |
| American Angle Ortho, LLC | United States | Maker | Buccal Tubes orthodontics | — | — |
| Funing Meitedental Factory | China | Maker | Orthodontic buccal tube | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Dental Tubes;Buccal Tubes;DTC;Orthodontics | — | — |
| Modern Orthodontics | India | Maker | ELFIN, AFIX | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | orthodontic buccal tube | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | TUBE, ORTHODONTIC | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS | — | — |
| Hansfive (Hangzhou) Dental Technology Co., Ltd. | China | Maker | Buccal Tubes | — | — |
| Univy Technology Advanced Co. Ltd | China | Maker | Buccal tubes | — | — |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd | China | Maker | Hangzhou 3B | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Orthodontic Tube | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Creative Dental | China | Maker | Tube | — | — |
| Yancheng KND Medical Instrument CO.,LTD | China | Maker | Buccal Tube | — | — |
| JINHUA GLAMB MEDICAL EQUIPMENT Co., Ltd. | China | Maker | Buccal Tubes | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| PSM Medical GmbH | Germany | Maker | — | — | — |
| Jin Hsiang Enterprise Co., Ltd. | Taiwan | Maker | Custom Orthodontic Tubes | — | — |
| Ricomed LLC | United States | Maker | RICOmed tubes | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| MPL Manufacturing Inc. | United States | Maker | — | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | — | — | — |
| Allure Ortho | United States | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Orthodontics, Tube | 23 | 2025 |
| Myofunctional Research Co. Usa Inc. | United States | Foreign exporter | Lingual Tubes BWS | 3 | 2026 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | Evolve Flow Tube · Evolve Tube | 2 | 2010 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | BUCCAL TUBE · orthodontic tube | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| Digital Dental Laboratories, Inc. DBA Orthodent | Canada | Manufacturer | Molar Tubes | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Jmu | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Nonconvertible Direct Bond Tubes | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | bondable buccal tube · Trumpax buccal tube · weldable buccal tube | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Buccal Tubes · Functional Tubes · Malibu Tubes · Stainless Steel Tubing · +4 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Double Buccal Tubes · Single Buccal Tubes · Triple Buccal Tubes | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Buccal Tubes | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| Forestadent Usa | United States | Repacker / relabeler | Alexander · Andrews · Aspire · BioQuick · +11 | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | Tube, Orthodontic | — | — |
| battech | United States | Repacker / relabeler | dental buccal tube | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | meridian · Novis · vortex | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Orthodontic Tube | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | ANCHOR BUCCAL TUBE · FAIRFIELD BUCCAL TUBES | — | — |
| Midwest Dental | United States | Repacker / relabeler | Advance Precision Premium Bonding Tubes · Advance Precision Series Bonding Tubes · Advance Pure ICE Bonding Tubes | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix Convertible Buccal Tubes · Phoenix Optimal | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Tangent Technologies LLC | United States | Contract manufacturer | Orthodontic Buccal Tubes and Orthodontic Metal Tubes | — | — |
| Mirabay Orthodontics Corporation | United States | Repacker / relabeler | KLEOS COMFY BUCCAL TUBES · KLEOS PSL BUCCAL TUBES | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 May 1995 | K943421 | ORTHODONITC ELASTOMERIC SLEEVING | Jon-Ko Products, Inc. |
| 2 Feb 1994 | K936243 | REGENCY TUBE | Ortho Specialties |
| 31 Jan 1994 | K935143 | DENTAURUM STAINLESS STEEL TUBING | Dentauraum, Inc. |
| 19 Sep 1991 | K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Aequitron Medical, Inc. |
| 9 Jan 1990 | K896586 | RATE INCREASE FOR IPPB/IPV | Percussionaire Corp. |
| 5 Apr 1984 | K834446 | ALEXOTEK LINGUAL TUBES | Alexotek Co. |
| 28 Feb 1984 | K834392 | LABIAL CUSPID TUBE | Alexotek Co. |
| 16 Feb 1978 | K780205 | ORTHODONTIC BUCCAL TUBE | Rocky Mountain Orthodontics, Inc. |
Official records: FDA product classification for DZD · 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