Dental device manufacturers in Poland
7 companies have an FDA-registered establishment in Poland, across 7 sites. 7 manufacture dental devices there or own their specifications.
What they make
Dental hand instruments5Implant instruments & surgical kits3Dental design & orthodontic software2Caries detection devices2Intraoral scanners2Clear aligners2Retainers, expanders & headgear2Impression trays2Orthodontic wires & bands2Dental burs & diamonds2Root canal filling materials2Rubber dam systems1Intraoral cameras1Denture cleansers & adhesives1
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Align Technology, Inc. | United States | Maker | iGo · iGo Plus · Invisalign ART · Invisalign Assist · +83 | 16 | 2026 |
| 3Shape A/S | Denmark | Maker | Ortho System · 3Shape Ortho System · 3Shape Splint Design · L1P-1F · +49 | 7 | 2020 |
| Solventum US LLC | United States | Maker | Impregum Penta Soft MB · VPS Tray Adhesive · Transbond LR · Transbond Supreme Adhesive, · +37 | — | — |
| Aesculap Chifa SP. Z O.O. | Poland | Maker | BAND HOLDERS · FURRER PLIERS · HOW LIGATURE PLIERS · SCISSORS, SURGICAL TISSUE, DENTAL · +14 | — | — |
| Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Koma | Poland | Maker | Orthodontic Wire CHIRMED · Dental Needle CHIRMED · Mouth Mirror CHIRMED · Orthodontic Ligature Tucking Instrument · +14 | — | — |
| Verdent Ltd. | Poland | Maker | Verdent · Verdent mouth mirrors · Verdent dental instruments · Verdent Gutta Percha points · +2 | — | — |
| Apollo Implant Components | Poland | Maker | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026