Therapeutic devices · 21 CFR 872 Subpart F
Indirect Bonding Tray
A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.
- Companies listing it
- 2926 makers
- Brands and models
- 28
- 510(k) clearances
- 00 in five years
- FDA name
- Indirect Bonding Tray
Companies that list QJJ
29 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | REF02 ClearCorrect System Engager Template · REF06 ClearCorrect System Engager Template | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Align Technology, Inc. | United States | Maker | Attachment Template | 16 | 2026 |
| SprintRay Inc. | United States | Maker | IDB 2 · IDB 3 | 8 | 2026 |
| Sybron Dental Specialties | United States | Maker | Ormco Digital Bonding | 203 | 2026 |
| Keystone Industries | United States | Maker | KeyPrint® KeyOrtho IBT | 2 | 2025 |
| Asiga | Australia | Maker | DentaIBT | 2 | 2025 |
| Zhejiang Yinchili Medical Technology Co.,Ltd | China | Maker | REF06 ClearCorrect System Engager Template | 2 | 2023 |
| Wuxi EA Medical Instruments Technologies Limited | China | Maker | Attachment Template | 2 | 2023 |
| Celebrace | United States | Maker | Celebrace Bonding Tray | 1 | 2025 |
| ASO International Manila, Inc. | Philippines | Maker | — | 1 | 2021 |
| OrthoSelect | United States | Maker | DIBS AI Indirect Bonding Tray | 1 | 2020 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Maker | Indirect Bond | — | — |
| Vedia Solutions, Division of Laxmi Dental Limited | India | Maker | Taglus IBT Resin | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | PriZma 3D Bio Ortho IBT | — | — |
| Xplora USA LLC | United States | Maker | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Maker | Indirect Bonding Tray | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | INDIRECT BONDING TRAY, OO Dental, OO MEDICAL, Orthodontic Indirect Bonding Tray, OBRACE GUIDE | — | — |
| Johns Dental Lab | United States | Maker | Indirect Bonding Tray | — | — |
| Alta Smiles, Inc | United States | Maker | Franks | — | — |
| Shenzhen Yongchanghe Technology Co., Ltd. | China | Maker | Ortho IBT resin | — | — |
| Xiamen Antinsky Industry Co., Ltd | China | Maker | Ortho IBT Resin | — | — |
| Microdental 2006 SL | Spain | Maker | Ferula | — | — |
| KLOwen Braces dba KLOwen Orthodontics | United States | Maker | KLOwen Orthodontic Solution | — | — |
| Angelalign Manufacturing Corp. | United States | Maker | Attachment Template | — | — |
| DMG Digital Enterprises SE | Germany | Maker | — | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone, Orthodontic Indirect Bonding Tray, OBRACE GUIDE | — | — |
| GLO Science, Inc. | United States | Contract manufacturer | Six Month Smiles PTK | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | REF06 ClearCorrect System Engager Template | — | — |
Official records: FDA product classification for QJJ · 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