Dental device manufacturers in Romania
2 companies have an FDA-registered establishment in Romania, across 2 sites. 2 manufacture dental devices there or own their specifications.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Kulzer, LLC | United States | Maker | Cuttersil Hardener · Cuttersil Light · CUTTERSIL MUCOSA · Cuttersil Putty Plus · +110 | 37 | 2026 |
| Eve Ernst Vetter GmbH | Germany | Maker | EVE | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026