Manufacturer registered with FDA
Unitron Group BV
IJzendijke, Netherlands. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Netherlands
Devices listed with FDA
What Unitron Group BV currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | GT Obturator Obturator OvenGT Series X Obturator OvenGuttamaster Obturator OvenProfile Vortex Obturator OvenProtaper Universal Obturator OvenThermaprep 2 Obturator OvenThermaprep Plus Obturator Oven | 2010 |
| Cervical (for Mild Sleep Apnea) PillowMYB · Class 2 | — | Maker | Lunoa SPT | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| UNITRON GROUP BVFDA reg. 3008388260 | IJzendijke Zeeland, Netherlands | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032425). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.