Prosthetic devices · 21 CFR 872 Subpart D
Preformed Bar
FDA device type “Bar, Preformed”.
- Companies listing it
- 2416 makers
- Brands and models
- 27
- 510(k) clearances
- 30 in five years
- FDA name
- Bar, Preformed
510(k) clearances per year, 1976–2026
Companies that list EHO
24 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Straumann Dental Implant System | 212 | 2026 |
| Stryker | United States | Maker | Archbar | 33 | 2024 |
| Panthera Dental Inc. | Canada | Maker | — | 5 | 2020 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Lingual bar · remanium palatal bar · remanium Quad Helix | — | — |
| Trimed Pvt Ltd | Pakistan | Maker | Coupling Part · Horizontal Bar Flexible · Horizontal Bar Non Flexible | — | — |
| Nobil Metal S p A | Italy | Maker | F.I.B. · LV BAR · LV CLI · LV HOR · +1 | — | — |
| Hebu Medical GmbH | Germany | Maker | Bar, Performed | — | — |
| Theia Holding SA | Switzerland | Maker | HADER ATTACHMENTS | — | — |
| Zhuhai DS Dental Technology Co., LTD | China | Maker | BAR, PREFORMED | — | — |
| HongKong DS DENTAL TECHNOLOGY CO. LIMITED | Hong Kong SAR China | Maker | BAR, PREFORMED | — | — |
| Nuvia MSO | United States | Maker | Nuvia Smiles 1 | — | — |
| Nuvia Smiles SAS | Colombia | Maker | Nuvia Smiles Bars | — | — |
| Foshan Nanhai Hongchen Medical Equipments Co.,ltd | China | Maker | Nova Ortho-Med Inc. | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| CreoDent Prosthetics LTD | United States | Repacker / relabeler | Bars | 9 | 2022 |
| Hu-Friedy Mfg Co., LLC | United States | Contract manufacturer | Hu-Friedy Mfg Co | 8 | 2012 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TORINO | — | — |
| STERIS Corporation | United States | Contract sterilizer | V. Mueller Dental Arch Bar (ST-CFE) | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | BAR, PREFORMED | — | — |
| SurgiPros LLC | United States | Repacker / relabeler | SURGIPROS | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 Aug 1994 | K934468 | SLIP-ON FIXATION SPLINT (SFS) | Gatewood Splints |
| 20 Jul 1989 | K881133 | 70-X/RVG (RADIOVISIOGRAPHY) | Trophy Radiologie |
| 6 Oct 1988 | K883388 | DENTREK BRIDGE BARS | Dale T. Dupuis |
Official records: FDA product classification for EHO · 21 CFR 872.3165.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026