Dental device manufacturers in Colombia
8 companies have an FDA-registered establishment in Colombia, across 8 sites. 7 manufacture dental devices there or own their specifications.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Materialise NV | Belgium | Maker | ProPlan CMF Guides · SurgiCase CMF Guides · TruMatch CMF Ti 3D-Printed Implants · TruMatch CMF Ti 3D-Printed Plates · +10 | 5 | 2026 |
| New Stetic, SA | Colombia | Maker | Duracryl · EZ-Cryl · Fidelity · Novacryl · +33 | 5 | 2026 |
| Masterdent Ltda. | Colombia | Maker | DAVINCI · RAFAEL · RESISTAL · STARDENT · +2 | 1 | 2000 |
| Placecol S.A. | Colombia | Maker | exempt | — | — |
| Maya Villegas S.A.S. | Colombia | Maker | BIOGENIC · DURODENT · MARFIL DIENTES · RITE-DENT | — | — |
| Macrolab Asociados S.A.S. | Colombia | Maker | Ecodent · Ecodent Mint * 100 yard | — | — |
| Nuvia Smiles SAS | Colombia | Maker | Nuvia Smiles Bars · Nuvia Smiles Dentures | — | — |
| ARTHREX Inc. | United States | Maker | AR-200 - Clips · Forceps, Rongeur, Surgical | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026